STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF MIDODRINE HYDROCHLORIDE

Sunny R. Salunke and Dr. Mrinalini C. Damle*

ABSTRACT

A simple and rapid stability indicating HPTLC method for Midodrine Hydrochloride was successfully developed. This method is based on HPTLC separation followed by UV detection at 290 nm. The separation was carried out on merck TLC aluminium sheets precoated with silica gel 60F254 using n-butanol: Methanol: water (6:2:2 v/v/v) as a mobile phase. Midodrine Hydrochloride gave well defined and sharp peak at Rf 0.30 ± 0.02. Calibration curve was linear in range 400-1200 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 Midodrine HCl. The suitability of this HPTLC method for quantitative determination of Midodrine Hydrochloridewas proved by validation in accordance with requirements of ICH guidelines.

Keywords: Midodrine Hydrochloride, HPTLC, Forced degradation, Validation.