SIMULTANEOUS ESTIMATION OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY HPTLC

Objective: The prevalence of Hypertension in India is estimated to be greater than 45% in the middle age population; elevated hypertension is one of the known causes of CHD, strokes and death. The objective of this work was to develop a simple, accurate and robust HPTLC method was developed for simultaneous estimation of Valsartan and Hydrochlorothiazide in bulk and tablets. Methods: The mobile phase optimized by HPTLC method consists of Toluene: Ethyl acetate: formic acid in the ratio of (3:7:0.3, v/v/v). The solvent front was a run-up to a distance of 80 cm; which took 15 min for the development of TLC plate. Analytical Wavelength for UV detection selected was at 225 nm. Results: Retention factor was found to be 0.74±0.02 and 0.45±0.02 for VAL and HTZ, respectively. Developed chromatographic method was validated as per ICH, Q2(R1) guidelines. Linearity was found at concentration range 300-1800 ng/spot (r2 = 0.999), 50-300ng/spot (r2 = 0.9991) for VAL and HTZ respectively. LOD were found to be 23.02 ng/spot and 4.12ng/spot respectively for Valsartan and Hydrochlorothiazide. LOQ was found to be 69.76ng/spot and 12.5ng/spot for, Valsartan and Hydrochlorothiazide respectively. Conclusion: Percentage RSD was found out to less than 2, indicating the developed method was precise and can be successively applied to pharmaceutical formulation. No interferences with the excipients were reported