A New RP-HPLC Method Development and Validation of Levosulpiride and Rabeprazole

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 (47.5?µg/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.

Introduction

Conclusion

A simple, rapid, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Rabeprazole and Levosulpiride in Tablet dosage form. The new RHPLC method developed and validated for simultaneous determination of Levosulpiride and Rabeprazole pharmaceutical dosage forms and assured the satisfactory precision and accuracy and also determining lower concentration of each drug in its solid combined dosage form by RP-HPLC method. The method was found to be simple, accurate, economical and rapid and they can be applied for routine analysis in laboratories and is suitable for the quality control of the raw materials, formulations, dissolution studies and can be employed for bioequivalence studies for the same formulation.

References

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Copyright

Copyright © 2023 Alekhya Somepalli, Nanda Gopala Krishna Gona, Sri lakshmi Avutu, Naga Sailaja Chandolu, Valli Padma Chilaka, Sony Priyanka Arava. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.