Method Development and Validation for Valsartan and Sacubitril by RP-HLPC

Abstract

The estimation of Saccubitril and Valsartan was done by RP-HPLC. The assay of Saccubitril and Valsartan was performed with tablets and the % assay was found to be 99.11and 100.76. and it’s linearity was found to be linear with a correlation coefficient of 0.999 and 0.99. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show precision 0.43 and 0.68. The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show precision 0.61 and 0.85. The accuracy limit is the percentage recovery should be in the range of 97.0% - 103.0%. The total recovery was found to be 100.34% and 100.22% for Saccubitril and Valsartan. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The acceptance criteria for LOD and LOQ is 3 and 10. The LOD and LOQ for Saccubitril was found to be 3.02 and 9.98 and LOD and LOQ for Valsartan was found to be 3.00 and 10.00. The robustness limit for mobile phase variation and flow rate variation are well within the limit.