Wednesday , 19 June 2024

Analytical Method Development and Validation for Rabeprazole and Itopride in API and Combine Pharmaceutical Dosage Forms by RP-HPLC

Sanju Srinivas1, M. Suman2
1Associate Professor Department of Pharmacy, Ganga Pharmacy College, Nizamabad, Telangana

2Department of Pharmaceutical Analysis, Ganga Pharmacy College, Nizamabad, Telangana

A new method was established for simultaneous estimation of Rabeprazole and Itoprideby RP- HPLC method. The chromatographic conditions were successfully developed for the separation of Rabeprazole and Itopride by using Agilent C18 column (4.6×150mm) 5µ , flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: Phosphate buffer (KH2PO4 and K2HPO4) pH  3  (pH  was adjusted  with  orthophosphoricacid), detection  wavelength was  254nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Rabeprazole and Itopride was found in concentration range of 50µ g-250µ g and 5µ g-50µ g and correlation coefficient (r2) was found to be 0.999 and 0.999.The precision study was precise, robust, and repeatable.

Keywords: Rabeprazole ,Itopride, RP-HPLC, Methanol.

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