医药导报2013，Vol.32Issue(2)：208-212,5.DOI:10.3870/yydb.2013.02.024
坎地沙坦酯片有关物质测定方法考察
Determination of Related Substances in Candesartan Cilexetil Tablets
摘要
Abstract
Objective To establish high performance liquid chromatography ( HPLC ) methods for determination of related substances in candesartan cilexetil tablets. Methods According to the quality standard of candesartan cilexetil tablets announced by State Food and Drug Administration (SFDA) , the related substances were determined on a Hypersil C18 column (250 mm×4. 6 mm, 5 μm) with the mobile phase of Methanol-acetonitrile-0. 05 mol · L-1 sodium dihydrogen phosphate solution (adjusted to pH 3.2 with phosphoric acid) (55 : 30 : 20) at a flow rate of 0. 9 mL · min-1 , detected at 254 mn wavelength. According to the standard of candesartan cilexetil tablets established by the Japanese Pharmacopoeia 16th Edition, the related substances were determined on a Waters C18 column ( 150 mm×4. 6 mm, 5 μm) with gradient elution of mobile phase A and B [A: acetonitrile-water-acetic acid (57 : 43 : 1), B: acetonitrile-water-acetic acid ( 90 : 10 : 1 ) ] at a flow rate of 0.9 mL · min-1 , detected at 254 mn. Results Five related substances of candesartan cilexetil could be determined by the method referred to SFDA. A good linear relationship was observed in the concentration range of 0. 25-25. 00 μg · mL-1. The detection limit was 1 ng. Eight related substances of candesartan cilexetil could be determined by the method referred to Japanese Pharmacopoeia. A good linear relationship was observed in the concentration range of 0. 40-40. 00 μg · mL-1 . The detection limit was 0. 8 ng. Conclusion Both of the determination methods could be used for the determination of related substances in candesartan cilexetil tablets. The method referred to Japanese Pharmacopoeia was proved to be more sensitive, specific, and accurate.关键词
坎地沙坦酯片/有关物质/色谱法,高效液相Key words
Candesartan cilexetil tablets/Related substances/High performance liquid chromatography分类
医药卫生引用本文复制引用
马超,苏慕君,臧可昕..坎地沙坦酯片有关物质测定方法考察[J].医药导报,2013,32(2):208-212,5.基金项目
国家重点基础研究发展计划(973计划)资助项目(2012CB724002) （973计划）
