Development and Validation of RP-HPLC Method for Simultaneous Estimation of Irbesartan and Simvastatin in Tablet Dosage Form

A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Irbesartan and Simvastatin from bulk and formulations. The proposed method was developed by HPLC Shimadzu Separation Module with PDA/UV detector connected to Empower software using Inertsil C18 ODS (4.6 x 250mm, 5mm) with an injection volume of 20 µl was injected and eluted with a mobile phase composition of Methanol: Acetonitrile (50:50), which is pumped at a flow rate of 0.8ml/min and detected by PDA detector at 245nm. Ambient column temperature has maintained. The total run time was 10mins.The retention time of Irbesartan and Simvastatin were found to be 2.9 min. and 4.1 min respectively. Linearity was observed in the concentration range of 0.2-0.8mg/ml for Irbesartan and Simvastatin respectively with correlation coefficient 0.999 for both the drugs. Percent recoveries obtained for both the drugs were98.0-101.50%, respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of Irbesartan and Simvastatin from their combined dosage form. Key words: RP-HPLC Method; Irbesartan and Simvastatin; Tablet dosage forms.