Development and Validation of A RP- HPLC Method for the Simultaneous Estimation of Valsartan and Sacubitril in Rat Plasma

Abstract

A basic precise selective, sensitive isocratic technique was developed and valid for the quantitative synchronic estimation of Sacubitril and Valsartan drug in rat plasma was by RP- HPLC system. The chromatographic activity separation was administrated out on Intersil C18 (250 x 4.6mm, 5μm) column with a mix of acetonitrile: di-potassium hydrogen phosphate, pH 3.0 adjusted with Phosphate buffer (30:70%v/v) as mobile part. The analytes were eluted with a rate of flow of 0.8ml/min and at a wavelength of 371nm of UV detection. The strategy was valid for precision, accuracy, linearity, Limit of detection, Limit of Quantification, Ruggedness following the ICH guidelines. The retention time was 10.725min and 15.366min and the system suitableness results was 99.95% and 100.24% for sacubitril and valsartan respectively. Linearity contemplate was completed between 100-500μg/ml and 5μg-25μg/ml, linear regression coefficient was observed to be 0.999 and the percentage recovery varies from 98-102% of Sacubitril and valsartan. No interference from any part of bulk and pharmaceutical dosage form was determined. All the parameters of validation are found to be at intervals within the vary that confirms the quality of the strategy for the determination of Sacubitril and Valsartan.