ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF FLUVASTATIN SODIUM AND VALSARTAN BY RP-HPLC TECHNIQUE

Abstract

A new simple, rapid reverse-phase high performance liquid chromatography method has been developed and validated for simultaneous estimation of Fluvastatin sodium and Valsartan in dosage forms. The estimation was carried out on an X-Terra C₁₈ column, while a mixture of acetonitrile: potassium dihydrogen ortho phosphate buffer (pH5) in ratio of 60:40% (v/v) as mobile phase. UV detection was performed at 237nm at flow rate of 0.7ml/min. The method was validated for specificity, sensitivity, linearity, accuracy and precision as per ICH guidelines. The retention time was found at 2.5 and 3.5 min for fluvastatin sodium and valsartan respectively. The calibration curve was linear over the concentration range of 20-60mcg/ml for fluvastatin and 40-120 mcg/ml for valsartan. The LOD and LOQ value were found to be 3.01 and 10.0mcg/ml for fluvastatin and 2.99 and 9.99 mcg/ml for valsartan. The developed and validated method has acquired accuracy and precision for routine analysis of fluvastatin sodium and valsartan in dosage form.