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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- Date Issued: 2010
Development and validation of a stability-indicating method for the quantitation of paclitaxel in pharmaceutical dosage forms
- 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.
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- Date Issued: 2009