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.
出处
《中国药品标准》
CAS
2011年第2期141-144,共4页
Drug Standards of China
