Abstract

Rapid, accurate and precise method for identification and quantitation of Olmesartan medoxomil (OLM) was developed by HPTLC-densitometry and validated. The Camag HPTLC system, employed with software winCATS (ver.1.4.1.8) was used for proposed analytical work. Planar chromatographic development was carried out with the help of Silica Gel 60 F254 pre-coated TLC plates. Sample application was facilitated by Linomat 5 applicator and ascending development in a previously saturated twin trough chamber was carried out, using Methanol: Toluene: Ethyl acetate: Glacial acetic acid (2.5, 5.5, 1.8, 0.2 % v/v/v/v) as the mobile phase and detection wavelength of 257 nm. In HPTLC densitogram well defined peak was obtained for OLM at 0.43. Performance characteristics of HPTLC method for estimation of OLM in bulk and its marketed dosage form were statistically validated as per recommendations of ICH guidelines of analytical method validation. The HPTLC method was found to be linear with R2 value of 0.9946 and across the range 40-400 ng/band. The developed method was found to be specific as the densitogram of pure OLM and tablet extract matched correctly. The LOD and LOQ values were found to be 2.68 and 8.13 ng/band respectively. The method was found to be accurate, precise, robust and economical for the analysis of OLM from bulk and its formulation. Thus this method can be safely employed for analysis of routine samples and quality control of drugs in pharmaceutical formulations.