Simultaneous RP-HPLC estimation and validation of ramipril and atorvastatin in bulk and combined tablet formulation

A Varma, J Shanmukha Kumar, S Reddy
2015 Journal of Chemical and Pharmaceutical Research   unpublished
A simple, precise, accurate and reproducible RP-HPLC method was developed and validated for simultaneous estimation of ramipril and atorvastatin in bulk and combined pharmaceutical formulations. Separation of ramipril and atorvastatin was successfully achieved on an Inertsil ODS C18 column (150mm x 4.6mm x 5 µm). The mobile phase consisted of 0.1% ortho phosphoric acid and methanol (60:40, v/v) at a flow rate of 1.2 ml/min. The detection was performed at 245 nm. The method was validated
more » ... g to ICH guidelines for linearity, sensitivity, accuracy, precision and robustness. The response was found to be linear in the concentration range of 2.5 µg/ml to 7.5 µg/ml for ramipril and 10 µg/ml to 30 µg/ml for atorvastatin. The LOD and LOQ for ramipril were found to be 0.009 µg/ml and 0.029 µg/ml, respectively. The LOD and LOQ for atorvastatin were 0.0269µg/ml and 0.0898 µg/ml, respectively. The percentage recovery for ramipril and atorvastatin were found to be 100% and 101%, respectively. The excellent percentage recovery values indicate the high accuracy of the proposed method. The method specifically determines the analytes in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for linearity, range, accuracy, precision, specificity and robustness.