Journal of Chromatography & Separation Techniques
Open Access

Abstract

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

Seemi Siddiqui, Sarvesh Paliwal, Kanchan Kohli, Anees A Siddiqui and Kapendra Sahu

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 RT 4.95 min and forced degradation studies gave two degradation products such as one peak of degradation product of alkaline hydrolysis were observed at RRT 2.941(DP II) and at RRT 0.382 (DP I) a peak for acidic hydrolysis product obtained along with the drug peak at RT 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.