盐酸地芬尼多片剂一致性评价研究中酒石酸氢钾含量测定  

Determination of Potassium Hydrogen Tartrate in the Consistency Evaluation of Difenidol Hydrochloride Tablets

作　　者：王希 唐小鹏 吴泽君 刘水平 林仲仪 王玲兰 刘晶 李雪如 WANG xi;TANG Xiao-peng;WU Ze-jun;LIU Shui-ping;LIN Zhong-yi;WANG Ling-lan;LIU Jing;LI Xue-ru(Zhuzhou Institute for Food and Drug Control,Zhuzhou 412000,China;Hunan qianjinxiangjiang pharmaceutical co.LTD,Zhuzhou 412000,China)

机构地区：[1]株洲市食品药品检验所,湖南株洲412000 [2]湖南千金湘江药业股份有限公司,湖南株洲412000

出　　处：《海峡药学》2021年第1期5-8,共4页Strait Pharmaceutical Journal

基　　金：湖南省食品药品监督管理局食品药品安全科技项目(湘食药科R201618)。

摘　　要：目的建立液相色谱法(HPLC)测定盐酸地芬尼多片中酒石酸氢钾检测方法。方法采用Agilent 5 TC-C_(18)色谱柱(4.6 mm×250 mm,5μm),以0.1%磷酸溶液-甲醇(95∶5)为流动相;流速1.0 mL·min^(-1);检测波长为210 nm,柱温30℃。结果酒石酸氢钾与其他组分完全分离;酒石酸氢钾检测浓度的线性范围为10.25^205.0μg·mL^(-1)(r=0.9963);平均回收率为103.5%,RSD为2.1%。结论本方法简单、准确、灵敏度高、重复性好,可用于盐酸地芬尼多片中酒石酸氢钾的检测方法。OBJECTIVE To establish an HPLC method for the content determination of Potassium acid tartrate(KHC 4H 4O 6)in Difenidol hydrochloride.METHODS KHC 4H 4O 6 were separated on Agilent 5 TC-C 18 column(4.6 mm×250 mm,5μm).The mobile phase consisted of 0.1%phosphoric acid-methanol(95∶5)and the column temperature was 30℃.RESULTS KHC 4H 4O 6 and other component were completely separated.The linear ranges of determination was 10.25-205.0μg·mL-1(r=0.9963).The average recoveries was 103.5%(RSD=2.1%).CONCLUSION The method is simple,accurate,sensitive and reproducible,and it can use as a control method for determination of KHC 4H 4O 6 in Difenidol hydrochloride.

关 键 词：酒石酸氢钾 盐酸地芬尼多 液相色谱法 含量测定 

分 类 号：R94[医药卫生—药剂学]