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Published on: October 27, 2014
Development and validation of a stability-indicating method for the quantitation of Paclitaxel in pharmaceutical
Ali Mohammadi1, Farnaz Esmaeili, Rasoul Dinarvand
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, P.O. Box 14155-6451, Tehran 14174, Iran. alimohammadi@tums.ac.ir
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.
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