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

Seemi Siddiqui,Sarvesh Paliwal

doi:10.4172/2157-7064.1000135

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 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.

Highlights

Stress studies were carried out under the conditions mentioned in International Conference on Harmonization (ICH) Q1A (R2) viz dry heat, hydrolysis, oxidation and photolysis
Several analytical methods that have been reported for estimation of paclitaxel are high performance liquid chromatography (HPLC) [7,8] and LC-MS/MS [9,10]
Stress studies were performed under conditions of dry heat, hydrolysis, oxidation, and photolysis, as mentioned in ICH Q1A (R2)

Summary

Introduction

Stress studies were carried out under the conditions mentioned in ICH Q1A (R2) viz dry heat, hydrolysis, oxidation and photolysis. Regulatory guidance in ICH Q2A, Q2B, Q3B and FDA 21 CFR section 211 all requires the development and validation of stability indicating assays [1,2,3,4]. Paclitaxel is one of the broadest spectrum anticancer agent approved by the Food and Drug Administration FDA for the treatment of advanced ovarian cancer [5,6]. The literature shows that some analytical methods were developed for estimation of these drugs by individually or in combination with other drugs. Several analytical methods that have been reported for estimation of paclitaxel are HPLC [7,8] and LC-MS/MS [9,10]

Objectives

Methods

Results