Validated RP-UFLC Method Development of Paclitaxel in Pure and Pharmaceutical Dosage Form

摘要

Introduction: An accurate, precise and rapid method for analysis and quantification of paclitaxel by reverse phase ultra-fast liquid chromatography (RP UFLC) was developed and validated. Paclitaxel in bulk and formulations were analyzed and quantified. Methods: Paclitaxel in bulk and formulations were analyzed on phenomenex C18 column (250 mm×4.6 mm i.d., 5 μm particle size) as stationary phase. Mobile phase was composed of acetonitrile and phosphate buffer pH 4.5 in the ratio 50:50 at a flow rate of 1.0 mL/min. Elutes were analyzed using PDA detector at a detection wavelength of 282 nm. The proposed method was validated by ICH harmonized Tripartite guidelines, Validation of Analytical Procedures: Text and Methodology Q2 (R1). Results: In this study, the chromatographic peaks of paclitaxel showed good resolution with retention time of 6.5 min. Paclitaxel showed an excellent linearity with 0.994 of correlation coefficient. Other validation parameters including precision, specificity, accuracy, and robustness demonstrated good reliability in the quantification of paclitaxel. Conclusion: Thus the newly developed and validated method can be conveniently used for the quantification of paclitaxel in bulk and formulation. The method can also be applied to multicomponent drug analysis.