DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF SACUBITRIL AND VALSARTAN BY RP-HPLC

Santhapuram Prashathi*, G. Priyanka, K. Sujatha and Dr. Arumugam Yasodha

ABSTRACT

A reverse phase liquid chromatographic method for estimation of Sacubitril and Valsartan in bulk drugs and marketed pharmaceutical dosage form was developed and validated. The chromatographic conditions to achieve the highest performance parameters using Targetsil C18 (4.6×150mm, 5µ) Column with guard filter were optimized. The separation was carried out using a mobile phase containing Methanol: Phosphate Buffer pH 3.9 (55:45v/v) was taken in the ratio of 55: 45% v/v pumped at a flow rate of 1.0 mL/min with detection at 255 nm. The method was shown to be linear in 1-5μg/mL and 100-500μg/mL concentration range (regression coefficients of 0.9993 and 0.9994) for Sacubitril and Valsartan respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.07μg/mL and 0.18μg/mL & 0.2μg/mL and 54.8μg/mL for Sacubitril and Valsartan respectively. The accuracy of the method was assessed by adding fixed amount of pre-analyzed sample to different standard solutions (50%, 100%, and 150% of the tested concentration) in triplicate. The percentage mean recoveries were found to 98%- 102%. The method was found to be precise with %RSD value was found to be within the limits for intraday and interday precision study, respectively. The method specificity and robustness were also established. New and sensitive RP-HPLC method for estimation of Sacubitril and Valsartan has been developed, in respect to the reviewed analytical methods.

Keywords: Sacubitril and Valsartan, RP-HPLC, Accuracy, Precision, Robustness.