Abstract

METHOD DEVELOPMENT AND VALIDATION AND FORCED DEGRADATION STUDY ON RABEPRAZOLE SODIUM USING RPHPLC

Shashikant B. Bagade* and Sneh Shah

ABSTRACT

A simple and rapid stability indicating HPLC method was developed for the Rabeprazole sodium API. Here the HPLC method which was developed was capable of separating the degradants from the API which may be developed during the storage of the API or during the synthesis of the API. So here the degradation was carried out under the different hydrolytic conditions like acid, base and neutral and the HPLC method was develop to separate the degradants from API. The method which was developed have the methanol and phosphate buffer as a mobile phase and the detection was carried out at 283 nm and at a flow rate of 1 ml/ min.The retention time of Rabeprazole sodium was 8.98±0.10 minutes.Validation of the method was also performed in which Linearity, Precision, LOD & LOQ, Accuracy and robustness was performed.

Keywords: Rabeprazole sodium, HPLC, Stability Indicating Method, Validation, Forced degradation.