Method Deveopment and Method Validation for Simultaneous Evaluation of Ondansetron and Rabeprazole Solid Dosage Form Using Rp-HPLC Technique

Validation is an important concept in several industries, particularly those related to manufacturing, pharmaceuticals, and quality assurance. It entails a systematic approach to ensure that processes, systems, procedures, and equipment consistently execute their intended functions and provide dependable outcomes. Validation is critical for ensuring quality, adhering to regulatory standards, and reducing production and operational risks. The developed method was novel and simple for the simultaneous estimation of Ondansetron & Rabeprazole by RP-HPLC. The two peaks were well resolved at 275nm in isocratic mode at retention times 4.918 and 6.561 min for Ondansetron and Rabeprazole respectively at a run time of 15 min and flow rate 1.2ml/min with 250mm x 4.6mm, 5µm column & Ammonium acetate buffer: water: methanol (25:15:60) as mobile phase. % Assay values for Ondansetron and Rabeprazole were found to be 98.49% & 99.37% respectively. Linearity was obtained in the range of 16-48 ppm and linearity correlation coefficient was found to be 0.9995 & 0.9997 for Ondansetron and Rabeprazole respectively. This new approach was verified using ICH guidelines and found to be specific, sensitive, precise, accurate, and linear.