Abstract

RP-HPLC METHOD FOR ESTIMATION OF BOSUTINIB IN BULK FORM AS PER ICH GUIDELINES

Vidya L. Chaudhari* and Amol A. Kulkarni

Abstract

An accurate, Precise, Simple and Economical High Performance Liquid Chromatographic method for the estimation of Bosutinib in bulk form has been developed. The drug were resoled using a methanol and potassium dehydrogenase Phosphate Buffer 10 mm ph. 5.9 mixed in a proportion of 90:10 v/v as mobile phase on an Primesil C18 column (Length: 250nm, Diameter: 4.6nm, Particle size: 5μ). The linearity for the method was observed in a concentration range of 10- 50μg/mL with the correlation coefficient of 0.998. The retention time for Bosutinib was found to be 6.9 min. Detection wavelength chosen was 266 nm. The accuracy studies of RP-HPLC method was performed at three different levels, i.e. 80%, 100%, 120% and recovery was found to be in the range of 99.58 to 101.25% for Bosutinib respectively. The method so developed was validated in compliance with the regulatory guidelines by using well developed Analytical method validation tool which comprises with the analytical method validation parameters like Linearity, Accuracy, Method precision, Specificity, System suitability, Robustness and Ruggedness. The results obtained were well within the acceptance criteria.

Keywords: Bosutinib, RP-HPLC, Method development, Validation.