DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC AND ION PAIR CHROMATOGRAPHIC TECHNIQUE FOR ESTIMATION OF VALSARTAN AND HYDROCHLOROTHIAZIDE

Two new simple, sensitive, rapid, accurate and reproducible methods (UV-spectrophotometric and ion pair chromatography) have been developed for simultaneous estimation of valsartan (VAL) and hydrochlrothiazide (HCTZ) from their tablet dosage form. The first method involves multiwavelength spectrophotometric method (Method 1) in which interference of HCTZ at 245nm (wavelength for estimation of VAL) was removed by recording absorbance difference at 245nm and 301 nm whereas HCTZ was estimated directly from its absorbance at 316 nm at which VAL shows no absorbance. Linearity of the response was demonstrated by VAL in the concentration range of 5-45 g/ml with a square correlation coefficient (r2) of 0.9998. Linearity of the response was demonstrated by HCTZ in the concentration range of 2-18 g/ml with a square correlation coefficient (r2) of 0.9994. The second method utilizes ion pair chromatography (Method 2) on a HIQ sil ODS column (250 mm* 4.6 mm i.d.) using methanol: 0.0025 M orthophosphoric acid: (70:30 by volume) having pH 4.6: 0.1% hexane sulphonic acid as mobile phase with UV detection at 259nm over concentration range for VAL is 240-0 μg/ml, and for HCTZ is 75-0μg/ml. Losartan potassium was used as the internal standard. The suggested procedures were checked using laboratory prepared mixtures and were applied successfully for the analysis of their tablet dosage form. The results of analysis were statistically analysed. Both the methods were validated as per ICH Q2B guideline