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气相色谱法测定金感胶囊中盐酸金刚烷胺的含量

Content determination of amantadine hydrochloride in Jingan Capsule by gas chromatography

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【作者】 唐娟杨淑婷宋菲陆苑李勇军蒋坤王爱民

【Author】 TANG Juan;YANG Shu-ting;SONG Fei;LU Yuan;LI Yong-jun;JIANG Kun;WANG Ai-min;Provincial Key Laboratory of Pharmaceutical Pharmaceutics in Preparation of Guizhou Province;Engineering Research Center for the Development and Application of Ethnic Drug and Traditional Chinese Medicine Chinese Materia Medica, Ministry of Education;National Engineering Research Center of Miao’s Medicines;School of Pharmacy, Guizhou Medical University;Guizhou Bailing Group Pharmaceutical Co., Ltd;

【机构】 贵州省药物制剂重点实验室民族药与中药开发应用教育部工程研究中心国家苗药工程技术研究中心贵州医科大学药学院贵州百灵企业集团制药股份有限公司

【摘要】 目的:建立金感胶囊中盐酸金刚烷胺的含量测定方法。方法:采用气相色谱法,色谱柱为ZB-5毛细管柱(30m×0.32mm,0.25μm),FID检测器,进样口温度为250℃,检测器温度为300℃,柱温为程序升温,初始柱温为100℃,保持2min,以20℃/min的速率升温至220℃,再以60℃/min的速率升温至280℃,保持1min,载气为氮气,恒压模式,柱前压为70kPa,分流进样,分流比5∶1。结果:盐酸金刚烷胺进样浓度在0.05016-1.00320mg/mL线性关系良好(r=0.9998),平均回收率(n=9)为100.9%。阴性样品不干扰测定。结论:所建立的毛细管气相色谱法简单、灵敏、准确、重复性好,可用于金感胶囊中盐酸金刚烷胺含量的测定及质量控制。

【Abstract】 Objective: To establish a gas chromatography(GC) method for the determining the content of amantadine hydrochloride in Jingan Capsule. Methods: The GC was performed on a ZB-5 capillary column(30 m×0.32 mm, 0.25μm) with a flame ionization detector(FID). The injector temperature was 250oC and detector temperature was set at 300oC. The temperature program of column oven was set as follows: 100oC for 2 min, increased to 220oC at a rate of 20oC/min, then at 60oC/min to 280oC, held for 1 min. The carrying gas was nitrogen(70 k Pa), and the injection spilt ratio was 5:1. Results: The calibration curve of amantadine hydrochloride was in good linear correlation in the concentration rang of 0.05016-1.00320 mg/mL(r=0.9998). The mean recovery(n=9) was 100.9%. Negative sample did not interfere with the determination. Conclusion: This established method is simple, sensitive, accurate and reproducible. It can be used for determination of amantadine hydrochloride in Jingan Capsule and the quality control of Jingan Capsule.

【基金】 现代药物研究开发协同创新中心(No.黔教合协同创新字201304);贵州省民族药与中药开发应用工程技术研究中心(No.20134001);药剂学研究生卓越人才计划(No.2014012);贵州省民族药药效物质基础研究科技创新人才团队(No.20165613);贵州省高层次创新型人才培养(百层次)贵州省科学技术厅人才团队项目(No.20165677)~~
  • 【文献出处】 中华中医药杂志 ,China Journal of Traditional Chinese Medicine and Pharmacy , 编辑部邮箱 ,2018年03期
  • 【分类号】O657.71;R927.2
  • 【被引频次】5
  • 【下载频次】190
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