Abstract

Ajinkya A. Deosthali and Mrinalini C. Damle*

ABSTRACT

A simple, rapid validated stability indicating HPTLC method of Acebrophylline was successfully developed. This method is based on HPTLC separation afollowed by UV detection at 248 nm and 273 nm. The separation was carried out on merck TLC aluminium sheets precoated with silica gel 60F254 using toluene: methanol (5:5 v/v) as a mobile phase. Acebrophylline gave well defined and sharp peak at Rf 0.48 ± 0.02 at 273 nm and 0.85±0.02 at 248 nm. Calibration curve was linear in range 500-2500 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 non-interference by product of degradation. This method can be applied to determination of stability of Acebrophylline. The suitability of this HPTLC method for quantitative determination of Acebrophylline was proved by validation in accordance with requirements of ICH guidelines.