In vitro dissolution kinetics of Captopril from microspheres manufactured by solvent evaporation
- Authors: Khamanga, Sandile M , Walker, Roderick B
- Date: 2012
- Language: English
- Type: text , Article
- Identifier: vital:6390 , http://hdl.handle.net/10962/d1006311
- Description: The aim of this study was to develop and assess captopril-loaded microspheres in which Methocel and Eudragit RS were used as release-controlling factors and to evaluate captopril (CPT) release using kinetic models. Drug-excipient interactions were evaluated using infrared studies, and the physical appearance was characterized using scanning electron microscopy (SEM). A burst effect was observed during the first stage of dissolution for most batches of microspheres. SEM results reveal that this may be attributed to dissolution of captopril crystals that were present on the surface, embedded in the superficial layer of the matrix materials, trapped near the surface of the microspheres, or that may have diffused rapidly through the porous surface of the capsules. The release data generated during in vitro release studies were fitted to zero-order, first-order, Higuchi, Korsmeyer–Peppas, Kopcha, and Makoid–Banakar models. The release kinetics of captopril from most formulations followed a classical Fickian diffusion mechanism. SEM photographs showed that diffusion took place through pores located in the surface of the microcapsules. The Kopcha model diffusion and erosion terms showed a predominance of diffusion relative to swelling or erosion throughout the entire test period. The drug release mechanism was also confirmed by the Makoid–Banakar and Korsmeyer–Peppas model exponents. This further supports a diffusion–release mechanism for most formulations. The models postulate that the total drug released is a summation of several mechanisms (viz., burst release, relaxation-induced controlled release, and diffusional release). These results also support the potential application of Eudragit/Methocel microspheres as a suitable sustained-release drug delivery system for captopril.
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The use of response surface methodology to evaluate the impact of level 2 SUPAC–IR changes on the in vitro release of metronidazole and ranitidine from a fixed-dose combination tablet
- Authors: King’ori, Loti D , Walker, Roderick B
- Date: 2012
- Language: English
- Type: text , Article
- Identifier: vital:6391 , http://hdl.handle.net/10962/d1006313
- Description: The purpose of this study was to evaluate the effect of different levels of disintegrant (croscarmellose sodium, CCS), binder (polyvinylprrolidone K30, PVP–K30), and lubricant (magnesium stearate) on the in vitro release of metronidazole (MTZ) and rantidine (RTD) from a solid oral fixed-dose combination tablet. The excipient levels investigated were Level 2 changes in component and composition described in the Scale-Up and Post Approval Changes for Immediate Release (SUPAC–IR) guidance (1). Batches of tablets (1000 units) were manufactured by wet granulation using a Saral high-shear mixer granulator and a Manesty B3B rotary tablet press. Weight uniformity, friability, and disintegration of all tablets were assessed, and all batches complied with compendial specifications. The amount of drug released (Q) at ten minutes was dependent on the levels of CCS in the formulation, and the effect of PVP–K30 and magnesium stearate was dependent on the levels of CCS. Synergistic interactions between independent variables were observed for the Q10 value for RTD, whereas PVP–K30 and magnesium stearate exhibited an antagonistic effect on the Q10 values for MTZ and RTD. The use of response surface methodology facilitated an investigation into the effect of Level 2 component and composition changes, as described in SUPAC–IR, on the in vitro release of MTZ and RTD from a fixed-dose combination (FDC) solid oral dosage form (SODF).
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Evaluation of the kinetics and mechanism of drug release from Econazole nitrate nanosponge loaded Carbapol Hydrogel
- Authors: Sharma, Renuka , Walker, Roderick B , Pathak, Kamla
- Date: 2011
- Language: English
- Type: text , Article
- Identifier: vital:6437 , http://hdl.handle.net/10962/d1006614
- Description: The objective of this study was to investigate the mechanism of release of econazole nitrate (EN) nanosponges loaded hydrogel and to compare it with EN hydrogel so as to develop an extended release topical drug delivery system of EN. Nanosponges of EN were prepared using ethyl cellulose and PVA by emulsion solvent evaporation method. On the basis of pharmacotechnical evaluation nanosponges with least particle size of 230.1 nm and good rheological properties were formulated as hydrogel (F1 – F7). In vitro drug release data of EN nanosponges loaded hydrogels in phosphate buffer pH 6.8 and 7.4 when analysed by GraphPad Prism software version 4.0 San Diego, USA best fitted the Makoid-2 Banakar model (R value greater than 0.98). The Korsmeyer-Peppas release exponent (n) ranged between 0.331 – 0.418, which confirmed diffusion as the principle mechanism of drug release. The release mechanism was further confirmed by calculating the ratio of exponents A/B ratio derived from the Kopcha model.
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Analytical methods for the quantitative determination of oxytocin
- Authors: Chaibva, Faith A , Walker, Roderick B
- Date: 2010
- Language: English
- Type: Article
- Identifier: vital:6353 , http://hdl.handle.net/10962/d1006037
- Description: Oxytocin is a clinically important nonapeptide that is used for the induction and/or augmentation of labor and is normally administered as a slow intravenous infusion diluted with normal saline or Ringer’s lactate solution. Oxytocin is also indicated for use in the prevention and treatment of post partum hemorrhage and may be administered via either the intramuscular or intravenous routes in order to increase uterine tone and/or reduce bleeding. The analysis of oxytocin in different media has evolved over the past 30 years with the result that more sophisticated, selective and sensitive techniques are used for the determination of the compound. A variety of techniques have been applied to the determination of oxytocin in different matrices ranging from simple paper chromatography to hyphenated liquid chromatographic such as liquid chromatography coupled with mass-spectrometry. Additionally enzyme linked immuno-sorbent assays (ELISA) and radio immuno-assays (RIA) are used for the determination of low concentrations of oxytocin in biological matrices. This manuscript provides a systematic survey of the analytical methods that have been reported for isolation and quantitation of oxytocin in different matrices.
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Development of a stability-indicating high performance liquid chromatographic method for the analysis of topiramate and dissolution rate testing in topiramate tablets
- Authors: Mohammadi, Ali , Rezanour, Nasrin , Ansari Dogaheh, M , Walker, Roderick B
- Date: 2010
- Language: English
- Type: text , Article
- Identifier: vital:6412 , http://hdl.handle.net/10962/d1006507
- Description: A stability-indicating high performance liquid chromatographic(HPLC) method was developed and validated for the quantitation and dissolution determination of topiramate in tablet dosage forms. An isocratic separation was achieved using a phenyl column with a flow rate of 1 mL/min using UV detection at 264 nm. Topiramate has low UV absorbtivity and was subjected to derivatization with 9-fluorenylmethyl chloroformate (FMOC-Cl). The mobile phase for the separation consisted of acetonitrile: 50 mM sodium dihydrogen phosphate(NaH2PO4) containing 3 % v/v triethylamine (pH 2.8) in a 48:52 v/v ratio. Topiramate was subjected to oxidation, hydrolysis, photolysis and heat for the purposes of stress testing. Separation was achieved for the parent compound and all the degradation products in an overall analytical run time of approximately 15 min with the parent compound topiramate eluting at approximately 9.2 min. The method was linear over the concentration range of 1-100 μg/mL (r = 0.9996) with limits of quantitation and detection of 1 and 0.3 μg/mL, respectively.
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Optimization of salbutamol sulfate dissolution from sustained release matrix formulations using an artificial neural network
- Authors: Chaibva, Faith A , Burton, Michael H , Walker, Roderick B
- Date: 2010
- Subjects: Neural networks (Computer science)
- Language: English
- Type: Article
- Identifier: vital:6352 , http://hdl.handle.net/10962/d1006034
- Description: An artificial neural network was used to optimize the release of salbutamol sulfate from hydrophilic matrix formulations. Model formulations to be used for training, testing and validating the neural network were manufactured with the aid of a central composite design with varying the levels of Methocel® K100M, xanthan gum, Carbopol® 974P and Surelease® as the input factors. In vitro dissolution time profiles at six different sampling times were used as target data in training the neural network for formulation optimization. A multi layer perceptron with one hidden layer was constructed using Matlab®, and the number of nodes in the hidden layer was optimized by trial and error to develop a model with the best predictive ability. The results revealed that a neural network with nine nodes was optimal for developing and optimizing formulations. Simulations undertaken with the training data revealed that the constructed model was useable. The optimized neural network was used for optimization of formulation with desirable release characteristics and the results indicated that there was agreement between the predicted formulation and the manufactured formulation. This work illustrates the possible utility of artificial neural networks for the optimization of pharmaceutical formulations with desirable performance characteristics.
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Simultaneous determination of irinotecan hydrochloride and its related compounds by high performance liquid chromatography using ultraviolet detection
- Authors: Mohammadi, Ali , Esmaeili, Farnaz , Dinarvand, Rassoul , Atyabi, Fatemeh , Walker, Roderick B
- Date: 2010
- Language: English
- Type: Article
- Identifier: vital:6413 , http://hdl.handle.net/10962/d1006508
- Description: A new simple, precise and accurate high performance liquid chromatography (HPLC) method was developed and validated for the simultaneous determination of irinotecan (CPT-11) and two related compounds viz., 7-ethyl-10 hydroxycamptothecin (SN-38) and camptothecin (CPT) in pharmaceutical dosage forms. Chromatography was accomplished using a reversed-phase C18 column and ultraviolet (UV)detection and an isocratic mobile phase consisting of 3 % v/v triethylammonium acetate buffer (pH 3) and acetonitrile (70:30 v/v). The linear range of quantitation for all the compounds was 0.1-10 μg/mL. The limit of quantitation for all the compounds ranged between 0.01-0.05 μg/mL. The method has the requisite accuracy, selectivity, sensitivity and precision to assay of CPT-11 and related compounds in pharmaceutical dosage forms and bulk API.
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The determination of acetaminophen using a carbon nanotube: graphite-based electrode
- Authors: Moghaddam, Abdolmajid B , Mohammadi, Ali , Mohammadi, Somaye , Rayeji, Danyal , Dinarvand, Rassoul , Baghi, Mansoureh , Walker, Roderick B
- Date: 2010
- Language: English
- Type: Article , text
- Identifier: vital:6414 , http://hdl.handle.net/10962/d1006509
- Description: The oxidation of acetaminophen was studied at a glassy carbon electrode modified with multi-walled carbon nanotubes and a graphite paste. Cyclic voltammety, differential pulse voltammetry and square wave voltammetry at various pH values, scan rates, and the effect of the ratio of nanotubes to graphite were investigated in order to optimize the parameters for the determination of acetaminophen. Square wave voltammetry is the most appropriate technique in giving a characteristic peak at 0.52 V at pH 5. The porous nanostructure of the electrode improves the surface area which results in an increase in the peak current. The voltammetric response is linear in the range between 75 and 2000 ng.mL−1, with standard deviations between 0.25 and 7.8%, and a limit of detection of 25 ng.mL−1. The method has been successfully applied to the analysis of acetaminophen in tablets and biological fluids.
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Synthesis of molecularly imprinted polymer for selective solid-phase extraction of Salbutamol from urine samples
- Authors: Mohammadi, Ali , Alizadeh, Taher , Dinarvand, Rassoul , Ganjali, Mohammed M , Walker, Roderick B
- Date: 2009
- Language: English
- Type: Article
- Identifier: vital:6410 , http://hdl.handle.net/10962/d1006496
- Description: A highly selective methacrylic based molecularly imprinted polymer (MIP) was synthesized and applied for the separation and the pre-concentration of salbutamol in urine samples. Spectrophotometric determination of salbutamol was achieved using 2,6-dichloroquinone chlorimide as colorimetric reagent. The detection limit of the method was ca. 13 ng/mL in urine after pre-concentration of the samples by MIP-SPE andanalysis with an optimized and sensitive spectrophotometric method. The linear dynamic range for salbutamol determination in urine was 0.04-0.75 μg mL-1. The recovery for the affinity based solid-phase extraction (SPE) with the MIP was more than 96 %.
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The evaluation of Eudragit microcapsules manufactured by solvent evaporation using USP Apparatus 1
- Authors: Khamanga, Sandile M , Parfitt, Natalie R , Nyamuzhiwa, Tsitsi , Haidula, Hendrina , Walker, Roderick B
- Date: 2009
- Language: English
- Type: text , Article
- Identifier: vital:6389 , http://hdl.handle.net/10962/d1006310
- Description: The objectives of this study were to prepare microcapsules containing verapamil and propranolol and to evaluate the kinetics and mechanism of drug release from the microcapsules using USP Apparatus 1. The effects of polymer concentration and polymer type on the cumulative amount of drug released were evaluated. The microcapsules were manufactured using Eudragit RS and RL polymers by solvent evaporation with the ultimate aim of prolonging drug release. Twenty-four formulations were prepared using different drug/polymer ratios. The effects of polymer type and polymer/drug ratios on the size, flow properties, surface morphology, and the release characteristics of the microcapsules were examined. The effects of drug inclusion methods on drug loading, encapsulation efficiency, and release properties of the complex microcapsules were also investigated. The formulations containing drug/polymer ratio 1:4 (w/w) were the most appropriate with respect to encapsulation efficiency (70%), flow properties (HR = 1.2), drug loading (15–20%), and drug release characteristics, in all cases. The release kinetics from the different formulations followed mainly a diffusion-controlled mechanism.
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Shoppers Drug Mart or poachers Drug Mart?
- Authors: Attaran, Amir , Walker, Roderick B
- Date: 2008
- Language: English
- Type: Article
- Identifier: vital:6346 , http://hdl.handle.net/10962/d1006018
- Description: [From the text]: Shoppers Drug Mart (Pharmaprix in Quebec) is a familiar Canadian institution. Its 1000 stores dot the landscape; no pharmacy chain is larger. In many Canadian communities, the corporation's well-staffed local franchises give patients quality care. However, in South Africa, the same corporation is potentially contributing to a public health disaster. In 2005, 2006 and twice in 2007, it has dispatched recruiters to that country, with the mission of plucking pharmacists from a continent that has far too few for its needs. Shoppers Drug Mart promises 6-figure salaries and help to establish a brilliant career in Canada. The carrot, and the helping hand holding it, are huge.
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Should active recruitment of health workers from sub-Saharan Africa be viewed as a crime?
- Authors: Mills, E J , Schabas, W A , Volmink, J , Walker, Roderick B , Ford, N , Katabira, E , Anema, A , Joffres, M , Cahn, P , Montaner, J
- Date: 2008
- Language: English
- Type: Article
- Identifier: vital:6392 , http://hdl.handle.net/10962/d1006314
- Description: (Conclusion) When the international community permits for-profit companies to actively entice overworked and often underpaid workers away from the most vulnerable populations, it is contributing to the deterioration of essential health-care delivery. Improvement of the health of the world’s poor is a challenge that the international community is failing to adequately address. Current international treaties and commitments are severely compromised if we are unwilling to adhere to their principles and prevent obvious harms to poor people. Clear, enforced regulation is needed to prevent recruitment companies from enticing health workers away from their local work, and developed countries should adequately compensate less-developed countries for the human resources they have lost and continue to lose.
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Study of the formation of artifacts following Dichloromethane reaction with some nitrogenous drugs
- Authors: Mohammadi, Ali , Amini, Mohsen , Hamedani, Moteza P , Torkabadi, Hossein H , Walker, Roderick B
- Date: 2008
- Language: English
- Type: Article
- Identifier: vital:6409 , http://hdl.handle.net/10962/d1006495
- Description: In this work, the quaternization reaction of some nitrogenous drugs in dichloromethane under stress condition and room temperature at different times are studied. Under these conditions, drug-chloromethochloride adducts or artifacts were found to be formed for clozapine, ofloxacin and olanzapine. The structures of the resultant adducts were elucidated using 1H NMR spectroscopy. In addition, the amount of intact drug was determined using in-house validated HPLC methods with UV detection.
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A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets
- Authors: Mohammadi, Ali , Rezanour, N , Ansari Dogaheh, M , Ghorbani Bidkorbeh, F , Hashem, M , Walker, Roderick B
- Date: 2007
- Language: English
- Type: Article
- Identifier: vital:6403 , http://hdl.handle.net/10962/d1006340
- Description: A simple, rapid, precise and accurate isocratic reversed-phase stability-indicating HPLC method was developed and validated for the simultaneous determination of atorvastatin (AT) and amlodipine (AM) in commercial tablets. The method has shown adequate separation for AM, AT from their associated main impurities and their degradation products. Separation was achieved on a Perfectsil® Target ODS-3, 5 μm, 250 mm × 4.6 mm i.d. column using a mobile phase consisting of acetonitrile–0.025 M NaH2PO4 buffer (pH 4.5) (55:45, v/v) at a flow rate of 1 ml/min and UV detection at 237 nm. The drugs were subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. The linearity of the proposed method was investigated in the range of 2–30 μg/ml (r = 0.9994) for AT and 1–20 μg/ml (r = 0.9993) for AM. The limits of detection were 0.65 μg/ml and 0.35 μg/ml for AT and AM, respectively. The limits of quantitation were 2 μg/ml and 1 μg/ml for AT and AM, respectively. Degradation products produced as a result of stress studies did not interfere with the detection of AT and AM and the assay can thus be considered stability-indicating.
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The comparison of in vitro release methods for the evaluation of oxytocin release from Pluronic® F127 parenteral formulations
- Authors: Chaibva, Faith A , Walker, Roderick B
- Date: 2007
- Language: English
- Type: Article
- Identifier: vital:6351 , http://hdl.handle.net/10962/d1006033
- Description: The objective of these studies was to develop a discriminatory in vitro release test for assessing formulation factors that may affect oxytocin (OT) release during formulation development studies of a Pluronic® F127 OT in situ gel-forming parenteral dosage form. An appropriate release assessment method should be able to discriminate between the performance of different formulation compositions (1, 2), and this was the primary criterion used for selection of an appropriate test procedure during the test method development process. ANOVA and the difference (f1) and similarity (f2)factors were used to evaluate the discriminatory behavior of different test methods that were investigated in these studies. The in vitro release tests that were investigated included the use of USP Apparatus 1, 2, and 3; a dialysis bag in USP Apparatus 2; and a membrane-less diffusion method. It was concluded that the use of USP Apparatus 3 was best able to discriminate between OT release for the different formulations tested. USP Apparatus 3 was thus considered the most suitable in vitro release test apparatus for studying formulation factors affecting OT release during the development of a parenteral dosage form prepared using Pluronic® F127.
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The effects of buffer molarity, agitation rate and mesh size on verapamil release from modified release mini-tablets using USP Apparatus 3
- Authors: Khamanga, Sandile M , Walker, Roderick B
- Date: 2007
- Language: English
- Type: text , Article
- Identifier: vital:6386 , http://hdl.handle.net/10962/d1006307
- Description: The effects of agitation rate, buffer molarity,and mesh size on the dissolution rate of verapamil hydrochloride from sustained release matrix tablets were studied using USP Apparatus 3. Eudragit® and Carbopol® were used as rate-retarding polymers in tablets prepared by wet granulation.The study was conducted to determine whether the drugs exhibit similar release characteristics when tested under the same dissolution conditions. It was found that the dissolution rate of verapamil hydrochloride was affected by the variables assessed in these studies.
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A stability-indicating high performance liquid chromatographic assay for the determination of orlistat in capsules
- Authors: Mohammadi, Ali , Haririan, I , Rezanour, I , Ghiasi, L , Walker, Roderick B
- Date: 2006
- Language: English
- Type: Article , text
- Identifier: vital:6407 , http://hdl.handle.net/10962/d1006480
- Description: A stability-indicating HPLC method was developed and validated for the quantitative determination of orlistat in capsule dosage forms. An isocratic separation was achieved using a Perfectsil® target ODS-3, 250 mm × 4.6 mm i.d., 5 µm particle size column with a flow rate of 0.7 ml/min and using a UV detector to monitor the eluate at 210 nm. The mobile phase consisted of methanol:acetonitrile:trifluoroacetic acid (82.5:17.5:0.01, v/v/v). The drug was subjected oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 15 min with the parent compound orlistat eluting at approximately 9 min. The method was linear over the concentration range of 0.02–0.75 mg/ml (r = 0.9998) with a limit of detection and quantitation 0.006 and 0.02 mg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay orlistat in capsules. Degradation products resulting from the stress studies did not interfere with the detection of orlistat and the assay is thus stability-indicating.
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Development and validation of a stability-indicating analytical method for the quantitation of oxytocin in pharmaceutical dosage forms
- Authors: Chaibva, Faith A , Walker, Roderick B
- Date: 2006
- Language: English
- Type: Article
- Identifier: vital:6349 , http://hdl.handle.net/10962/d1006030
- Description: A single stability-indicating assay for oxytocin (OT) in pharmaceutical dosage forms using gradient elution over 21 min has been reported in the literature. Furthermore, published and compendial methods for the analysis of OT containing dosage forms also involve using HPLC with gradient elution and complicated mobile phases that include hydrophobic ion pairing agents. A simple isocratic and stability-indicating assay was developed and validated. The conditions are as follows, column: Phenomenex® C18 Hypersil, 5 μm packing, 4.6 mm × 150 mm with acetonitrile–phosphate buffer (pH 5; 0.08 M) (20:80) as the mobile phase with UV detection at 220 nm The method was found to be specific for OT in the presence of degradation products and chlorbutol (preservative) with an overall analytical run time of 16 min. Accuracy was determined to be 0.77–1.18% bias for all samples tested. Intra-assay precision (repeatability) was found to be 0.22–1.04%R.S.D. while the inter-day precision (intermediate precision) was found to be 1.27–1.68%R.S.D. for the samples studied. The calibration curve was found to be linear with the equation y = 1.81x + 0.02 and a linear regression coefficient of 0.9991 over the range 0.4–12.0 IU/ml. The LOD and the LOQ were determined to be 0.1 and 0.4 IU/ml, respectively. Syntocinon®, a commercially available dosage form of OT was assayed resulting in 100.5–106.6% recovery of the label claim and an average of 10.04 IU/ml.
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An LC-MS-MS method for the determination of cyclizine in human serum
- Authors: Mohammadi, Ali , Kanfer, Isadore , Sewram, V , Walker, Roderick B
- Date: 2005
- Language: English
- Type: Article
- Identifier: vital:6408 , http://hdl.handle.net/10962/d1006481
- Description: Cyclizine is a piperazine derivative with anti-emetic activity that is useful in the prevention and treatment of nausea and vomiting associated with motion sickness. A liquid chromatography-tandem mass spectrometry (LC-MS-MS) method is presented for the quantitation of cyclizine in serum. Sample pretreatment involved liquid-liquid extraction of 200 μl of serum with dichloromethane after the addition of 100 μl each of ammonium hydroxide and internal standard solutions. The extracts were analyzed by HPLC on a Luna ® C18 reversed-phase column and an ion-trap mass spectrometer with an electrospray interface. A limit of detection of 1 ng/ml was determined which allowed for the reliable measurement of cyclizine in the serum of human subjects. The method was found to be linear over the calibration range of 2.5-100 ng/ml. The applicability of this method was demonstrated by the analysis of serum obtained from a human volunteer following administration of a single 50 mg cyclizine hydrochloride tablet. The reported method was observed to have the necessary sensitivity, selectivity, precision and accuracy for monitoring cyclizine concentrations in human subjects following oral administration.
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A capillary zone electrophoresis (CZE) method for the determination of cyclizine hydrochloride in tablets and suppositories
- Authors: Mohammadi, I , Kanfer, Isadore , Walker, Roderick B
- Date: 2004
- Language: English
- Type: Article
- Identifier: vital:6406 , http://hdl.handle.net/10962/d1006479
- Description: Current compendial methods of assay for the analysis of cyclizine tablets involve the use of UV spectrophotometry. Since this is a non-selective technique its application to more complex dosage forms, such as suppositories, is unlikely to be appropriate. There is therefore a need for the development of a highly specific quantitative analytical method, such as high performance liquid chromatography (HPLC) or capillary electrophoresis (CE). The latter technique was chosen in view of some specific advantages over HPLC, such as the use of relatively non-toxic aqueous buffers, as opposed to organic solvents, which obviates the use of expensive HPLC grade solvents making CE more cost effective. Cyclizine was analyzed in 50 mM phosphate buffer (pH 2.3) and run at an applied voltage 25 kV. Detection sensitivity was enhanced by using a wavelength of 200 nm and samples were loaded hydrodynamically onto an uncoated fused-silica capillary (60 cm×50 mm i.d.). Chlorcyclizine was used as the internal standard and resolution of both compounds was achieved in less than 7 min. Stress testing was undertaken in order to investigate the appearance of breakdown products. The method has the requisite accuracy, selectivity, sensitivity and precision to assay cyclizine in tablets and suppositories. Degradation products resulting from the stress studies did not interfere with the detection of cyclizine and the assay is thus stability-indicating.
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