Validated RP-HPLC Method for simultaneous determination of Atorvastatin and Ramipril and its application in drug formulation

[摘要] A rapid, sensitive and specific RP-HPLC method involving UV detection was developed and validated for determination and quantification of Atorvastatin and Ramipril. Chromatography was carried out on a Phenomenex – Luna, C18 (250 x 4.6 mm i.d.,5μ) column. using filtered and degassed mixture of acetonitrile ,water and methanol (55:40:5) as mobile phase at a flow rate of 1.0 ml/min and effluent was monitored at 237nm. The method was validated in terms of linearity, precision, accuracy and specificity. The assay was linear over the concentration range of 5.0- 25.0 mcg/ml and 2.5 to 12.5 mcg/ml for Atorvastatin and Ramipril respectively. Accuracy of the method was determined through recovery studies by adding known quantities of standard drug to the pre analyzed test solution and was found to be 98.5-99.96% and 99.99%-100.25% within precision RSD of 1.04 and 1.24 for Atorvastatin and Ramipril respectively. The method requires less than 10 minutes as run time for analysis which prove the adoptability of the method for the routine quality control of the drug.

[学科分类] 药理学