Abstract

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF BOCEPREVIR

Mrinalini C. Damle* and Sunny R. Salunke

Abstract

A simple, accurate, precise and rapid validated stability indicating HPTLC method of Boceprevir was successfully developed. This method is based on HPTLC separation followed by UV detection at 215 nm. The separation was carried out on merck TLC aluminium sheets precoated with silica gel 60F254 using Ethyl Acetate:Toluene (6:4, v/v) as a mobile phase. Boceprevir gave well defined and sharp peak at Rf 0.42 ± 0.02. Calibration curve was linear in range 2000- 10000 ng/band. Stress degradation study shows that sample degraded with acid and base hydrolysis, under oxidation, thermal and photolytic stress conditions. The peak purity parameter ensured noninterference by product of degradation. This method can be applied to determination of stability of Boceprevir. The suitability of this HPTLC method for quantitative determination of Boceprevir was proved by validation in accordance with requirements of ICH guidelines.

Keywords: Boceprevir, HPTLC, Forced degradation, Validation.