Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ramipril, Aspirin and Simvastatin in Bulk and Pharmaceutical Dosage Form

Abstract

Objective: The objective of present work was to develop and validate a simple, fast, precise, selective and accurate RP-HPLC method for the simultaneous determination Ramipril(RAM), Aspirin (ASP) and Simvastatin (SIM) in a Pharmaceutical dosage form. Materials and Methods: The separation of these three drugs was achieved on a SHISHEDO C 18 , 250×4.6mm, 5 micron size column with a mobile phase consisting of 0.5% Ortho phosphoric acid :ACN:Methanol(20:10:70 v/v)  at a flow rate of 1ml/min and UV detection at 226nm. Results: The retention times were observed to be 2.1, 2.7 and 9.6 minutes for Ramipril (RAM), Aspirin (ASP) and Simvastatin (SIM) respectively. Linearity was found to be 5-15μg/ml, 50-150μg/ml, 20-60μg/ml for Ramipril(RAM), Aspirin(ASP)and Simvastatin(SIM) respectively. The method was statistically validated for linearity, recovery, limit of detection, limit of quantification, accuracy and precision. The stress testing of the drugs individually and their mixture is carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation conditions and its degradation products are well resolved from the analyte peaks Conclusion: This method was successfully validated for accuracy, precision, and linearity, limit of detection and limit of quantification. Keywords: Ramipril(RAM), Aspirin (ASP) Simvastatin (SIM)reverse phase high performance liquid chromatography.