DEVELOPMENT AND VALIDATION OF BIOANALYTICAL RP-HPLC METHOD FOR DETERMINATION OF VALSARTAN AND DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF VALSARTAN IN BULK DRUG AND FORMULATION

New bioanalytical method developed for determination of valsartan is highly accurate, sensitive, precise, robust. This analytical method developed can also be applied for determination of valsartan in bulk drug and in formulation also. Validation is performed as per ICH guidelines. A new method was established for estimation of Valsartan by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Valsartan by using Kromosil C₁₈ 4.5×150 mm 5.0 µm, flow rate was 0.8ml/min, and mobile phase ratio was 75:25% v/v ACE: di-potassium hydrogen phosphate, detection wavelength was 247 nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 6.323 mins. The % purity of Valsartan was found to be 99.87%. The system suitability parameters for Valsartan such as theoretical plates and tailing factor were found to be 4146, 1.23. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Valsartan was found in concentration range of 30µg-150µg and correlation coefficient (r²) was found to be 0.997, % recovery was found to be 100.4%, % RSD for repeatability was 0.5, % RSD for intermediate precision was 1.0. The precision study was precision, robustness and repeatability. LOD value was 2.97 and LOQ value was 9.92. Hence the suggested RP-HPLC method can be used for routine analysis of Valsartan in API and Pharmaceutical dosage form.