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作 者:刘德胜[1] 徐玉文 栾海云[1] 云飞[1] 陈向明[1]
机构地区:[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
出 处:《中国药品标准》2011年第2期141-144,共4页Drug Standards of China
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1.0mL·min-1,检测波长220nm。结果:盐酸噻氯匹定在0.05~0.15nag·mL-1浓度范围内与峰面积呈良好的线性关系(r=0.9999)。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。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.
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