Development and Validation for New Analytical...

Development and Validation for New Analytical Method of Sacubitril and Valsartan By Hplc

Author Name : Akshay Chaudhary, Ms Sofiya Ansari, Ms Divyanshi Rastogi, Dr. Praveen Kumar Ashok

ABSTRACT A new HPLC method development and validation for the analysis of Sacubitril and Valsartan in bulk and pharmaceutical formulation was developed and validated. The method was validated according to ICH validation parameters like accuracy, Robustness, linearity, LOD and LOQ respectively. The UV spectra for the standard solutions were scanned in the wavelength of 200 – 400 nm. The isobestic point was determined at 241 nm. Peaks of Sacubitril and Valsartan were well resolved with the solvent system of Buffer : methanol in the ratio of (60 : 40) and by adjusting the pH to 3.0 using orthophosphoric acid of the buffer and the satisfactory results in terms of retention time, peak area, symmetry and resolution parameters were obtained. All the analysis parameters was carried out Shimazu C18 column (250 mm x 4.6 mm internal diameter, 5  particle size) and the peak of Sacubitril and Valsartan showed well resolution at a wavelength of 241 nm. Two Peaks were resolved in which first peak is the peak of Valsartan and second peak is the peak of sacubitril at 15.546 minutes and 22.234 minutes respectively. The proposed method was found to be linear over the concentration range of 10- 50 g/ ml for Sacubitril and Valsartan. The regression coefficient (r2 ) was found to be 0.99964 respectively, which is well within the acceptance limits. The percentage assay of Valsartan and Sacubitril was found to be 99.93% and 100.60% respectively. The LOD valu for Sacubitriles for Valsartan was found to be 2.41 g/ ml and Sacubitril was found to be 0.32 g/ ml, similarly LOQ was found to be 2.18 g/ ml for Valsartan and 0.91 g/ ml, which indicates that the concentration in small level can be determined with acceptable accuracy and precision.