Development and validation of a stability-indicating method for the quantitation of paclitaxel in pharmaceutical dosage forms
- Mohammadi, Ali, Esimaeili, Farnaz, Dinarvand, Rasoul, Atyabi, Fatemeh, Walker, Roderick B
- Authors: Mohammadi, Ali , Esimaeili, Farnaz , Dinarvand, Rasoul , Atyabi, Fatemeh , Walker, Roderick B
- Date: 2009
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/184278 , vital:44196 , xlink:href="https://doi.org/10.1093/chromsci/47.7.599"
- Description: A simple, rapid stability-indicating isocratic assay has been developed and validated for the determination of Paclitaxel (PTX) in commercial injection formulations. The assay is performed using a Nucleosil RP-18 (5 µm, 250 × 4.0 mm i.d) column protected by a Nucleosil C18 precolumn (5 µm, 4.0 × 4.0 mm i.d.) with a mobile phase of methanol–water (80:20) and UV detection at 230 nm. The method was found to be specific for PTX in the presence of degradation products with an overall analytical run time of ~ 9 min. Accuracy reported as % bias was found to be 0.1–2.5% bias for all samples tested. Intra-assay precision (repeatability) was found to be 0.22–2.65% RSD, while inter-day precision (intermediate precision) was found to be 1.0–3.0% RSD for the samples studied. The calibration curve was found to be linear with the equation y = 29.78x + 7.65, and a linear regression coefficient of 0.9994 over the concentration range 0.05–20 µg/mL. The limits of quantitation and detection were 0.05 and 0.02 µg/mL, respectively. Taxol (30 mg/5 mL), a commercially available dosage form of PTX, was assayed and 100.6–103.6% of the label claim was recovered.
- Full Text:
- Date Issued: 2009
- Authors: Mohammadi, Ali , Esimaeili, Farnaz , Dinarvand, Rasoul , Atyabi, Fatemeh , Walker, Roderick B
- Date: 2009
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/184278 , vital:44196 , xlink:href="https://doi.org/10.1093/chromsci/47.7.599"
- Description: A simple, rapid stability-indicating isocratic assay has been developed and validated for the determination of Paclitaxel (PTX) in commercial injection formulations. The assay is performed using a Nucleosil RP-18 (5 µm, 250 × 4.0 mm i.d) column protected by a Nucleosil C18 precolumn (5 µm, 4.0 × 4.0 mm i.d.) with a mobile phase of methanol–water (80:20) and UV detection at 230 nm. The method was found to be specific for PTX in the presence of degradation products with an overall analytical run time of ~ 9 min. Accuracy reported as % bias was found to be 0.1–2.5% bias for all samples tested. Intra-assay precision (repeatability) was found to be 0.22–2.65% RSD, while inter-day precision (intermediate precision) was found to be 1.0–3.0% RSD for the samples studied. The calibration curve was found to be linear with the equation y = 29.78x + 7.65, and a linear regression coefficient of 0.9994 over the concentration range 0.05–20 µg/mL. The limits of quantitation and detection were 0.05 and 0.02 µg/mL, respectively. Taxol (30 mg/5 mL), a commercially available dosage form of PTX, was assayed and 100.6–103.6% of the label claim was recovered.
- Full Text:
- Date Issued: 2009
Synthesis of molecularly imprinted polymer for selective solid-phase extraction of Salbutamol from urine samples
- Mohammadi, Ali, Alizadeh, Taher, Dinarvand, Rassoul, Ganjali, Mohammed M, Walker, Roderick B
- 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 %.
- Full Text:
- Date Issued: 2009
- 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 %.
- Full Text:
- Date Issued: 2009
The evaluation of Eudragit microcapsules manufactured by solvent evaporation using USP Apparatus 1
- Khamanga, Sandile M, Parfitt, Natalie R, Nyamuzhiwa, Tsitsi, Haidula, Hendrina, Walker, Roderick B
- 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.
- Full Text:
- Date Issued: 2009
- 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.
- Full Text:
- Date Issued: 2009
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