Abstract
Abstract: The Present study was conducted to obtain a new, affordable, cost-effective and convenient method for RP- HPLC determination of Rabeprazole and Levosulpiride in tablet dosage form. The experiment was carried out according to the official specifications of USP–30, ICH- 1996 and Global Quality Guidelines-2002.The method was validated for the parameters like system suitability , selectivity, linearity, accuracy, precision ,LOD, LOQ, and robustness. 20mg Rabeprazole and 75mg Levosulpiride was dissolve in 100 ml of Diluent (1:1,Methanol:Na2HPO4) and was further diluted to get stock solution of Rabeprazole and Levosulpiride (47.5µg/ml). This is taken as a 100% concentration. Solution containing mixture of Rabeprazole and Levosulpiride of five different concentrations (50%,75%, 100% 125%, and 150% of target concentration) were prepared in the same way. System suitability study of the method was carried out by six replicate analysis of solution containing 100% target concentration of Rabeprazole and Levosulpiride. Various chromatographic parameters such as retention time, peak area tailing factor, theoretical plates (Tangent) of the column and resolution between the peaks were determined and the method was evaluated by analyzing these parameters. . % Recovery was 98.6% for Levosulpiride and 98.7% for Rabeprazole. All the results indicate that the method is highly accurate, retention time for standard sample and commercial product of Rabeprazole and Levosulpiride are same. This proves that, excipients have no effect on the analytical method. On the other hand, blank peak did not overlap drug peak. So the method is highly selective. The method is highly precise as % RSD of peak area was less than 2% in all tests
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