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两种测定盐酸噻氯匹定胶囊溶出度方法的比较
引用本文:刘德胜,徐玉文,栾海云,云飞,陈向明.两种测定盐酸噻氯匹定胶囊溶出度方法的比较[J].中国药品标准,2011,12(2):141-144.
作者姓名:刘德胜  徐玉文  栾海云  云飞  陈向明
作者单位:1. 滨州医学院药学院,山东烟台,264003
2. 山东省药品检验所,济南,250101
摘    要:目的:建立HPLC法测定盐酸噻氯匹定胶囊溶出度,与UV法比较溶出度测定的差异。方法:采用ODS-3 C18色谱柱,柱温35℃,流动相为0.022%戊烷磺酸钠溶液-磷酸盐缓冲液-甲醇-乙腈(26∶55∶23∶15),流速1.0 mL.min-1,检测波长220nm。结果:盐酸噻氯匹定在0.05~0.15 mg.mL-1浓度范围内与峰面积呈良好的线性关系(r=0.999 9)。结论:该法灵敏、准确,适用于盐酸噻氯匹定胶囊溶出度的测定。

关 键 词:盐酸噻氯匹定胶囊  溶出度  UV法  HPLC法

Comparison on two Dissolution Methods of Ticlopidine Hydrochloride Capsules
Authors:Liu De-sheng  Xu Yu-wen  Luan Hai-yun  Yun Fei and Chen Xiang-ming
Institution:Liu De-sheng 1,Xu Yu-wen2,Luan Hai-yun,Yun Fei1,Chen Xiang-ming1(1.Collge of Pharmacy,Binzhou Medical College,Yantai 264003,2.Shandong Provincial Institute for Drug Control,Jinan 250101)
Abstract:To establish an HPLC method for the determination of dissolution in Ticlopidine Hydrochloride Capsules by comparison two dissolution methods of ticlopidine hydrochloride capsules. A ODS-3 C18 column with UV detection at 220 nm, and a mixture of 0. 022% sodium pentanesulfonate solution -phosphate BS -methanol-acetonitrile (26: 55:23:15 ) as the mobile phase were used. The flow rate was 1.0 mL · min - 1, and the temperature of the column was 35℃. An excellent separation was achieved for Ticlopidine Hydrochloride and excipient, the calibration curve was linear in the range of 0. 05 - 0. 15 mg · mL-1 of Ticlopidine Hydrochloride, r = 0. 999 9. This method was accurate, simple, quick and effective for determination of dissolution in Ticlopidine Hydrochloride Capsules.
Keywords:Ticlopidine Hydrochloride Capsules  dissolution  UV  HPLC  
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