DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF SORAFENIB TOSYLATE

Mrinalini Damle*, Suresh Choudhari and Sanchita Kale

ABSTRACT

Simple, rapid validated stability indicating HPLC method for estimation of Sorafenib tosylate was successfully developed. The separation was achieved by using a mobile phase of Methanol: Water (pH 3 adjusted with Glacial Acetic Acid) in the ratio of 80:20 v/v using HiQ SiL C18 column (150 × 4.6 mm i.d.5 μm) at 1 ml/min as flow rate. The detection was carried out at 265 nm using PDA detector. The retention time observed was 5.5±0.2 min. This drug was subjected to stress conditions as per ICH Q1A (R2). Linearity was found to be in the concentration range of 10-50μg/ml with r2 =0.9909. The suitability of this HPLC method for quantitative estimation of Sorafenib was proved by validation in accordance with requirements of ICH guidelines Q2A (R1).

Keywords: Sorafenib Tosylate, HPLC, Stress degradation, Validation, ICH guidelines.