RP-HPLC Method for Estimation and Stress Degradation Study of Paclitaxel as per ICH Guidelines

Abstract

A simple, accurate, selective & reproducible validated stability indicating assay method was developed for determination of Paclitaxel in presence of its degradation products. The best separation was achieved in the C18 analytical column at ambient temperature using a mobile phase composed of acetonitrile and phosphate buffer (60:40) in isocratic mode. The flow rate was set at 1.0 ml/min and detection wavelength was 226 nm. The drug gives peak at R T 4.95 min and forced degradation studies gave two degradation products such as one peak of degradation product of alkaline hydrolysis were observed at RR T 2.941(DP II) and at RR T 0.382 (DP I) a peak for acidic hydrolysis product obtained along with the drug peak at R T 4.95. The limit of detection (LOD) and limit of quantitation (LOQ) of developed method were found to be 2 µg/ml and 10 µg/ml respectively. The validation results obtained from the analysis also reveals that the developed method is specific and selective.