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

Abstract

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 microm, 250 x 4.0 mm i.d) column protected by a Nucleosil C(18) precolumn (5 microm, 4.0 x 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 microg/mL. The limits of quantitation and detection were 0.05 and 0.02 microg/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.