Study on dissolution test of Telmisartan and Hydrochlorothiazide Tablets

GUO Yan

Abstract：Objective To study the dissolution behavior of telmisartan and hydrochlorothiazide in Telmisartan and Hydrochlorothiazide Tablets in four different dissolution media. Methods According to the dissolution test conditions in Ja-pans"quality of medical drugs information set" and make choice of the dissolution medium in accordance with the physico-chemical properties of Telmisartan and Hydrochlorothiazide Tablets,different Telmisartan and Hydrochlorothiazide Tablets were inspected in pH 1. 2 solution(containing 0. 5% twelve sodium dodecyl sulfate),pH 4. 0 acetate buffer(containing 0. 5% twelve sodium dodecyl sulfate),pH 6. 8 phosphate buffer(containing 0. 25% twelve sodium dodecyl sulfate)and water (containing 0. 25% twelve sodium dodecyl sulfate)by HPLC,and the resemblance of release curves were compared with similarity factors( f2 )method. Results The assay displayed a good linearity over the concentration range of 20~50 μg· L-1 ,6~20 μg·L-1 for telmisartan and hydrochlorothiazide;In 4 different dissolution media,compared with telmisartan,f2 of hydrochlorothiazide was greater than 50. Conclusion The method was simple,accurate and reproducible for the dissolu-tion determination of this tablet;The dissolution of telmisartan had similar characteristics with hydrochlorothiazide in Telmis-artan and Hydrochlorothiazide Tablets.