中国药物警戒 ›› 2014, Vol. 11 ›› Issue (9): 528-530.

• 质量与工艺研究 • 上一篇    下一篇

高三尖杉酯碱及其制剂有关物质的研究

郭欢迎1, 王孝功2*, 张晓敏2, 高敏2, 丁莉芳2, 吴建中2, 刘海静1   

  1. 1陕西省食品药品检验所,陕西 西安 710016;
    2西安迪赛生物药业有限责任公司,陕西 西安 710016
  • 收稿日期:2014-06-04 修回日期:2016-02-03 出版日期:2014-09-08 发布日期:2016-03-02
  • 通讯作者: 王孝功,男,硕士,工程师,药物开发与质量研究。E-mail：xgwcat@163.com
  • 作者简介:郭欢迎,女,本科,工程师,药品质量分析与研究。

Research for Homobarringtonie and Related Substances of Its Preparations

GUO Huan-ying1, WANG Xiao-gong2, *, ZHANG Xiao-min2, Gao Min2, DING Li-fang2, WU Jian-zhong2, LIU Hai-jing1   

  1. 1Shanxi Institute for Food and Drug Control, Shanxi Xian 710016, China;
    2Xian Disai Biological Pharmaceutical Co.,Ltd, Shanxi Xian 710016, China
  • Received:2014-06-04 Revised:2016-02-03 Online:2014-09-08 Published:2016-03-02

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摘要： 目的建立RP-HPLC测定高三尖杉酯碱及其制剂有关物质的方法,并用其分析不同处理后高三尖杉酯碱有关物质的量。方法采用Germsil-P C18色谱柱（250×4.6 mm,5μm）,以10 mmol·L-1磷酸二氢钾溶液为流动相A,甲醇为流动相B,梯度洗脱,流速1 mL·min-1,检测波长288 nm,柱温30 ℃。结果高三尖杉酯碱在2~30 μg的范围内与峰面积呈良好的线性关系,r=0.9996;以高三尖杉酯碱进样量为20 μg重复进样6次,杂质A、杂质B、高三尖杉酯碱的RSD分别为3.28%,4.69%,1.12%。结论应用本方法精确可以测定高三尖杉酯碱中杂质A、杂质B等有关物质的量及高三尖杉酯碱的含量。

关键词: 高三尖杉酯碱, 有关物质, 高效液相色谱法

Abstract: ObjectiveTo build up RP-HPLC method for measuring homobarringtonie and related substances of its preparations, and to analyze the content of homobarringtonie related substances after different treatment. MethodsApply Germsil-P C18 chromatographic column (250×4.6 mm, 5 μm)and use 10 mmol·L-1 monopotassium phosphate as flow phase A while methanol as B. Apply gradient elution with the flow rate 1 mL·min-1, check the wavelength 288 nm with column temperature at 30 ℃. ResultsHomobarringtonie presented great linear relationship with peak area in the range of 2 ~30μg, with r=0.9996; when loading 20 μg homobarringtonie in 6 repeats, impurity A, impurity B, and homobarringtonie RSD were 3.28%, 4.69%, and 1.12%, respectively. ConclusionApplying this method can precisely measure the content of homobarringtonie, and related substances, such as impurity A and impurity B.

Key words: homobarringtonie, related substance, RP-HPLC

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