Development and Validation of Different Analytical Methods for Estimation of Antihypertensive Drugs in Pharmaceutical Dosage Form and Biological Fluids

Abstract

Results and Discussion: Different spectroscopy methods like first derivative method, Q-absorbance ratio method, absorbance correction method and zero absorbance method were developed for simultaneous estimation of aliskiren and valsartan, aliskiren and amlodipine, aliskiren, hydrochlorothiazide and aliskiren, olmesartan, hydrochlorothiazide and amlodipine in tablet formulations. Developed spectroscopy methods were validated according to ICH guidelines which include parameters like accuracy, precision, LOD, LOQ, range, linearity, accuracy and selectivity. All validation parameters were within their standard normal range as per ICH guidelines. For development of RP-HPLC method different parameters were optimized like mobile phase system, flow rate, detection wavelength and sample preparation techniques for good response of drugs. The developed RP-HPLC method was validated according to USFDA guideline which includes Parameters like accuracy, precision, LOD, LOQ, range, linearity, accuracy and stability and all the parameters show results within their normal standard range. For development of HPTLC method, mobile phase system was optimized for good separation of drugs. QbD approach was applied for validation of developed HPTLC method in which robustness study was carried out using central composite design to check the effect of mobile phase components and developing distant on Rf value of Drugs