Quantification of Sacubitril and Valsartan in tablet formulation By RP-HPLC Method

Abstract

A simple and rapid RP-HPLC method has been developed and validated for the simultaneous quantification of sacubitril and valsartan in bulk and marketing tablet formulation. The mobile phase used for the chromatographic separation consisted of methanol and water (60:40, v/v). The separation was achieved on an Enable C18 G (250 mm x 4.6 mm x 5 µm) column using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 245 nm. The method was linear in the concentration range 50-450 µg/ml for both sacubitril and valsartan. The method has been validated with respect to system suitability, specificity, precision, accuracy and robustness as per ICH guidelines. The limit of detection (LOD) and limit of quantification (LOQ) for sacubitril were 0.8 µg/ml and 2.45 µg/ml, respectively, while LOD and LOQ for valsartan were 0.97 µg/ml and 2.95 µg/ml respectively. The proposed method was found to be simple, precise, accurate and selective and can be successfully applied for the routine analysis of sacubitril and valsartan in API and combined tablet dosage form without any interference by the excipients.