Development and Validation of a Stability-Indicating Method for the Quantitation of Paclitaxel in Pharmaceutical Dosage Forms

• Published in: Journal of chromatographic science 2009-08, Vol.47 (7), p.599-604
• Main Authors: Mohammadi, Ali, Esmaeili, Farnaz, Dinarvand, Rasoul, Atyabi, Fatemeh, Walker, Roderick B.
• Format: Article
• Language: English
• Subjects: Analysis; Biological and medical sciences; Chromatography, High Pressure Liquid - methods; Drug Stability; General pharmacology; Medical sciences; Paclitaxel - chemistry; Pharmacology. Drug treatments; Reproducibility of Results; Technology, Pharmaceutical - methods
• ISSN: 0021-9665; 1945-239X
• DOI: 10.1093/chromsci/47.7.599

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.