摘要
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.关键词
替米沙坦氢氯噻嗪片/溶出曲线/高效液相色谱法/相似因子Key words
Telmisartan and Hydrochlorothiazide Tablets/Dissolution curves/HPLC/Similarity factor分类
医药卫生
