富马酸依美斯汀及其有关物质的HPLC法测定.pdfVIP

• 64 • 中国医药工业杂志 Chinese Joumal of Pharmaceuticals 2016, 47 (1) 富马酸侬美斯3丁及其有关物质的 HPLC 法测定 周一萌，周斌* (中国医药工业研究总院上海医药工业研究院，上海 201203) 摘要:建立了高效液相色谱法测定富马酸依美斯汀及其有关物质。使用 Zorbax Extend-C8 色谱柱，流动相为0.5%三乙胶 溶液(用磷酸调至pH 7.6) 甲醇;乙腊 (40 : 42 : 18) ，检测波长284 nrno 富马酸依美斯汀与有关物质的分离度良好。 富马酸依美斯汀在 0.05 ~ 1.0 mglml 范围内线性关系良好，平均回收率为 100.3%. RSD 为0.1 2% 。 关键词:富马酸依美斯汀:有关物质:高效液相色谱:测定 中图分类号: TQ460.7工 0657.7+2 文献标志码:A 文章编号: 1001-8255 (2016) 01-0064-03 DOI: 10.1 6522/ki.cjph .2016.0 1.017 Determination of Emedastine Difumarate and Its Related Substances by HPLC ZHOU Yimeng , ZHOU Bin* (Shanghai lnstitute ofPharmaceutica/ lndus町\ China State lnstitute ofPharmaceutica/ lndust.η Shanghai 201203) ABSTRACT: An HPLC method was established for the determination of emedastine difumarate and its related substances. A Zorbax Extend-C l8 column was used with the mobile phase of 0 .5%钉iethylamine solution (adjusted to pH 7.6 with phosphoric acid) : methanol : acetonitrile (40 : 42 : 18) at the detection wavelength of284 nm. Emedastine di缸marate and its related substances were separated successfully. It was linear in the concentration range of 0.05- 1.0 mglml for emedastine difumarate. 白le average recovery was 100.3 %, with RSD of0 .1 2%. Key Words: emedastine difumarate; related substance; HPLC; determination 富马酸依美斯汀 (emedastine difumarate , 1). IH-l ， 4- 二氮杂庚皖-1- 基) -lH- 苯并眯瞠二富马酸 化学名为 1- (2- 乙氧乙基) -2- (六氢 -4- 甲基. 盐，为组肢 HI 受体拮抗药，与同类药物相比，具 有强效、选择性高、起效快、不良反应少、耐受性 收稿日期: 2015-06-03 好和无心