ABSTRACT:
The simple, accurate and precise method for the quantitative determination of Rabeprazole sodium (RP) and Itopride hydrochloride (IH), from its tablet dosage form by HPTLC method, the chromatograms were developed using a mobile phase of Ethyl acetate : Methanol : Ammonia ( 8.5:1:0.5 v/v ) on precoated plate of silica gel 60 F254 and quantified by densitometric absorbance mode at 285 nm. The Rf values of IH and RP were 0.21 and 0.41 respectively. Linearity of Itopride hydrochloride (IH) and Rabeprazole sodium (RP) was in the range of 75 - 375 ng /ml and 10 - 50 ng /ml. Recovery studies of 98.88 – 102.41%, percentile relative std deviation of not more than 0.8 and correlation coefficient (linearity range) of 0.9954 – 0.9999 for IH and RP, it shows that developed methods were accurate and precise. The LOD and LOQ values were found to be 10ng/ml, 30ng/ml and 5ng/ml, 10ng/ml for IH and RP respectively. The mean percentage recovery values close to 100% it indicates there is no interferences of additives with Rabeprazole sodium (RP) and Itopride hydrochloride (IH) present in tablet dosage forms. The method has been validated as per ICH guide lines. This method can be employed for the routine analysis of tablets containing IH and RP.