Simultaneous quantification of levosulpiride and rabeprazole in tablet dosage form by validated normal phase high performance thin layer chromatographic method

Pravin Devidas Pawar, Sachin E

Abstract

A simple, sensitive, accurate, precise and robust high performance thin layer chromatographic method for simultaneous quantification of Levosulpiride and Rabeprazole in tablet dosage form has been developed and validated. Chromatographic separation was carried out on Merck precoated aluminium plates with silica gel 60 F254 as the stationary phase. Optimized mobile phase used was ethyl acetate: methanol: ammonia (8.5:1.5:0.2, v/v/v). Detection wavelength was 287 nm in reflectance-absorbance mode. The retardation factors (Rf) were found to be 0.25 ± 0.02 for Levosulpiride and 0.54 ± 0.02 for Rabeprazole. Linearity range was obtained between 100 – 1000 ng band-1 and 100 - 800 ng band-1 concentration of Levosulpiride and Rabeprazole respectively. The tablet dosage form analyzed was found to contain 99.02 ± 1 .32 %w/w of Levosulpiride and 101.46 ± 0.32 %w/w of Rabeprazole. The developed HPTLC method was validated as per ICH Q2 (R1) guideline. The proposed method can be applied for quality control testing of Levosulpiride and Rabeprazole in combined tablet dosage form.