RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CELECOXIB AND METFORMIN HYDROCHLORIDE IN SYNTHETIC MIXTURE

Prachi Vihol, Divyakant Patel, Janki Patel*

ABSTRACT

The Objective of this study was to develop and validate precise, accurate, and rapid RP-HPLC method for the simultaneous estimation of Celecoxib and Metformin Hydrochloride in a synthetic mixture as per ICH guidelines. In RP-HPLC method, the chromatographic system was equipped with Kromstar C18 (250 mm × 4.6 mm internal diameter × 5 μm particle size). and UV detector set at 231 nm and a Mobile Phase consisting of Phosphate buffer: Methanol: Acetonitrile (pH: 2.8 adjusted with 10% Ortho phosphoric acid) (52:28:20 % v/v/v) was used at a flow rate 1 ml/min. The retention time was found to be approximately 2.5 min for Metformin and 5.8 min for Celecoxib, ensuring proper separation of both drugs. The various analytical parameters, including specificity, linearity, LOD, LOQ, precision, accuracy, and robustness, were determined ICH guidelines. RP-HPLC method showed good linearity, precision, and accuracy with correlation coefficients close to 1. Recovery studies were within acceptable limits. Low LOD and LOQ values indicated high sensitivity. Percentage assay values were close to 100%, confirming the reliability of the developed method. The developed RP-HPLC method was found to be specific, accurate, precise, robust, economical, and reproducible. This method is suitable for routine quality control analysis of Celecoxib and Metformin Hydrochloride in synthetic mixtures.

Keywords: Celecoxib, Metformin Hydrochloride, Synthetic Mixture, RP-HPLC Method Development and Validation.