Abstract

N. D. Nizamuddin* and Desavath Sandeep Kumar Naik

ABSTRACT

Introduction: A new RP-HPLC method was developed for simultaneously estimating Rabeprazole and Pantoprazole. Separation was achieved using a Thermosil C18 column (4.0×125mm, 5μ) with a 0.7 ml/min flow rate and a mobile phase ratio of 70:30 (methanol: Sodium acetate buffer pH 3, adjusted with ortho phosphoric acid). Detection occurred at 252nm. The equipment used included the WATERS HPLC Auto Sampler, Separation module 2690, photo diode array detector 996, and Empower software version 2. Retention times were 2.566 mins for Rabeprazole and 3.417 mins for Pantoprazole. Purity percentages were 101.27% for Rabeprazole and 99.97% for Pantoprazole. System suitability parameters (theoretical plates, tailing factor, and resolution) were 4668, 1.3, and 6.0 for Rabeprazole and 6089, 1.2, and 6.0 for Pantoprazole. The method validation, following ICH guidelines, showed linearity in the 5-25μg range for Rabeprazole and 50-250μg for Pantoprazole, both with a correlation coefficient (r²) of 0.999. Recovery rates were 99.56% and 99.48%, with %RSD for repeatability at 0.86 and 0.82, and for intermediate precision at 0.44 and 0.19, respectively. The method proved precise, robust, and repeatable, with LOD values of 3.17 and 5.68, and LOQ values of 0.0172 and 0.2125, respectively.