Abstract

Yash V. Patel, Dr. Bhumi R. Patel*, Dr. Jaymin G. Patel, Ms. Pooja Soni, Ms. Janki A. Patel, Mr. Ronak N. Patel

ABSTRACT

A simple, precise, accurate, and stability-indicating RP-HPLC method was successfully developed and validated for the simultaneous estimation of Pantoprazole Sodium and Acotiamide Hydrochloride Hydrate in a synthetic mixture. Chromatographic separation was achieved using a Hibar ODS C18 column with a gradient mobile phase of buffer and acetonitrile, at a flow rate of 0.8 mL/min and detection at 221 nm. The developed RP-HPLC method showed excellent performance with good chromatographic separation of Pantoprazole Sodium and Acotiamide Hydrochloride Hydrate. The method exhibited strong linearity in the ranges of 4-20 µg/mL, 30-150 µg/ml, respectively. The LOD values were 0.169%, 0.689%, while LOQ values were 0.513%, 2.087%. Assay studies showed of 99.02±0.77, 100.38±0.98 respectively, indicating high reliability of the method. Overall, the method proved to be reliable and robust, making it suitable for routine quality control and analytical applications in pharmaceutical formulations. Therefore, the proposed method is suitable for routine quality control analysis and stability studies.