HPLC法测定盐酸氟桂利嗪口腔崩解片的含量(1)
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[摘要] 目的：建立盐酸氟桂利嗪口腔崩解片的HPLC含量测定方法。方法：采用shimadzu ODS C18色谱柱(150.0 mm×4.6 mm，5 μm)；流动相为甲醇-磷酸二氢钾(0.01 mol/L，pH=3.5)(68∶32)；流速为1.0 ml/min ；检测波长为254 nm；柱温：30℃。结果：盐酸氟桂利嗪浓度为4.8～57.6 μg/ml线性关系良好(r=0.999 9)；平均回收率为100.27%，RSD为1.00%(n=9)。结论：本方法简便、灵敏，精密度高，重现性好，可用于盐酸氟桂利嗪口腔崩解片的含量测定。
[关键词] 盐酸氟桂利嗪；口腔崩解片；高效液相色谱法；含量测定
[中图分类号] R286.0[文献标识码]A [文章编号]1674-4721(2011)04(b)-005-02
HPLC Determination of Flunarizine Hydrochloride Orally Disintegrating Tablets
WANG Jingxiang1,2, MU Vei1, CAO Deying2, TANG Xuting1
1.College of Chemical Engineering, Shijiazhuang University, Hebei Province, Shijiazhuang 050035, China; 2.College of Pharmaceutical Sciences, Hebei Medical University, Hebei Province, Shijiazhuang 050017, China
[Abstract] Objective: To establish HPLC determination method of Flunarizine Hydrochloride orally disintegrating tablets. Methods: HPLC analysis was carried out by using shimadzu ODS C18 column(150.0 mm×4.6 mm, 5 μm). Mobile phase was methanol-potassium dihydrogen phosphate (0.01 mol/L, pH=3.5)(68∶32); The flow rate was 1.0 ml/min. The detection wavelength was set at 254 nm and the column temperature was 30℃. Results: There was a good linear relationship for flunarizine hydrochloride in the range of 4.8-57.6 μg/ml(r=0.999 9). The average recovery was 100.27% (n=9) and RSD was 1.00%. Conclusion: This method is simple, sensitive, and accurate with good reproducibility. It can be used for the content determination for Flunarizine Hydrochloride orally disintegrating tablets.
[Key words] Flunarizine Hydrochloride; Oral disintegrating tablets; HPLC;Content determination
盐酸氟桂利嗪口腔崩解片的主要成分为盐酸氟桂利嗪，是一种选择性的钙通道阻断剂，临床常用于脑血栓形成、脑栓塞、脑动脉硬化、脑出血恢复期、脑外伤后遗症、内耳眩晕症、冠状动脉硬化等疾病的预防和治疗[1-3]。文献报道有原料药及胶囊剂和片剂的含量测定方法，包括电位滴定法、紫外分光光度法和高效液相色谱法[4-6]，而口腔崩解片的含量测定方法未见文献报道，因此，本文探索了HPLC法测定实验室制备的该制剂的含量，方法可靠，结果准确。
1 仪器与试药
1.1 仪器
FA-2104B电子天平(上海精密科学仪器有限公司)，UV-6100S紫外分光光度计(上海普美达仪器有限公司)，岛津SPD-10A高压液相色谱仪(日本岛津株式会社)；N2010工作站(浙江大学)。
1.2 试药
盐酸氟桂利嗪对照品(石家庄华新制药厂，批号：070216，含量99.62%)，盐酸氟桂利嗪口腔崩解片(实验室制备，规格5 mg)，甲醇为色谱纯，其他试剂为分析纯，水为高纯水。
2 方法与结果
2.1 色谱条件
色谱柱：shimadzu ODS C18柱(150 ......
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