摘要
目的:优化中国药典氯氮平片有关物质检测方法。方法:在国内外标准方法比较研究基础上建立了高效液相色谱法测定氯氮平有关物质。采用Kromsil C_(18)(4.6 mm×250 mm,5μm)色谱柱,梯度洗脱,流速:1.0m L·min^(-1),检测波长:257 nm,柱温:35℃;进样量:20μL。结果:优化后的方法能有效检出《中国药典》方法无法检出的氯氮平杂质B。结论:《中国药典》2015年版收载的氯氮平片有关物质检测方法无法检出氯氮平杂质B,优化后的方法能实现有效检出。
Objective: To optimize the related substances method of Clozapine Tablets in Chinese Pharmacopoeiacan. Methods: An HPLC method was established for the determination of the related substances of Clozapine Tablets. The chromatography analysis was performed on a KromsilC18 (250mm× 4.6mm, 5 m) column, gradient elution, the flow rate was 1.0mL·min-1, detection wavelength was 257nm, column temperature was 35 degrees, the injection volume was 20 μL. Results: The optimization method can achieve effective detect clozapine impurity B which the related substances method of Clozapine Tablets in Chinese Pharmacopoeia can not detect. Conclusion: Optimization method can achieve effective detection of the related substances method of Clozapine Tablets.
作者
陈爽
陈悦
邵鹏
刘小勤
CHEN Shuang;CHEN Yue;SHAO Peng;LIU Xiaoqin(Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China)
出处
《中国药品标准》
CAS
2018年第1期12-15,共4页
Drug Standards of China