Development and Validation of HPTLC Method for the Simultaneous Estimation of Gemifloxacin Mesylate and Ambroxol Hydrochloride in Bulk and Tablet Dosage Form

A new simple high performance thin layer chromatography method for simultaneous determination of gemifloxacin mesylate and ambroxol hydrochloride in bulk and tablet dosage form were investigated. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica ge160 F254 as a stationary phase and solvent system consisted of acetone:methanol:toluene:formic acid (4:2:3:1 v/v/v/v). Densitometric evaluation of the separated zones was performed at 252nm and the method was validated. The Rf values and drug content of gemifloxacin mesylate and ambroxol hydrochloride were 0.41±0.02, 0.68±0.02 and 100.1 %, 99.84 %. The calibration curves of peak area versus concentration, which was linear from 400–2200 ng/band for gemifloxacin mesylate, 100–550 ng/band for ambroxol hydrochloride and regression coefficient (r2) was greater than 0.99. LOD for gemifloxacin mesylate and ambroxol hydrochloride was 30 and 25 ng/band respectively, while LOQ was 100 and 70 ng/band respectively. The method was validated for linearity, accuracy, robustness as per International Conference on Harmonisation (ICH) guidelines. The study shows that the developed method is simple and accurate and it was found to be suitable for the simultaneous determination of gemifloxacin mesylate and ambroxol hydrochloride in bulk and pharmaceutical formulations. © 2012, Har Krishan Bhalla & Sons.