Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF PACLITAXEL IN PHARMACEUTICAL DOSAGE FORMS

Pallapati Suman, *Tirukkovalluri Siva Rao and Kallam Venkata Siva Rama Krishna Reddy

ABSTRACT

A simple, selective, precise, and stability indicating RP-HPLC method has been developed and validated for analysis of Paclitaxel, a chemotherapy medication used to treat different types of cancer. The chromatographic separation was achieved on a Agilent ZORBAX Eclipse Plus C18 column with Methanol: Acetonitrile: water (40:40:20 v/v), as mobile phase at a flow rate of 0.9mL/min. Detection was performed at 237nm and a sharp peak was obtained for Paclitaxel at a retention time of 7.12min. The calibration curve showed a good linear relationship between response and concentration with the equation y = 6816x + 67048, and the regression coefficient was 0.999 over the concentration range 20-120μg/mL. The limit of detection (LOD) and limit of quantification (LOQ) were 0.04μg/mL and 0.15μg/mL respectively. The method was validated for accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. The method was successfully separated the degraded products from the stress degradation conditions. The wide linearity range, accuracy and simple mobile phase imply the method is suitable for routine quantification of Paclitaxel with high precision.

Keywords: Paclitaxel, RP- HPLC, Stress degradation, CANTAXEL© – 30mg, ICH.