摘要
目的优化克拉霉素片溶出度检测方法。方法采用ZORBAX SB-C18(4.6 mm×150 mm,5μm)色谱柱,流动相:磷酸盐缓冲液∶乙腈(60∶40),流速:1.0 ml/min,检测波长:210 nm;柱温:45℃,进样量:50μl。在药典方法基础上去掉稀释步骤,以每批次6片样品分别经溶出仪溶出后直接经高效液相色谱仪测定后按外标法以限度计算溶出度。结果本法与药典方法相比较,溶出度结果一致,均大于限度80%,符合限度要求。结论本研究方法可以作为克拉霉素片溶出度的质量控制方法。
Objective To optimize the dissolution test of Clarithromycin tablets.Methods ZORBAX SB-C18(4.6 mmx150 mm,5μm)chromatographic column was used,mobile phase:phosphate buffer solution:acetonitrile(60:40),flow rate:1.0 ml/min,detection wavelength:210 nm,column temperature:45℃,injection volume:50μL.We removed dilution steps on the basis of the Pharmacopoeia method,dissolution of 6 tablets in each batch was determined by high performance liquid chromatography after dissolution by dissolution analyzer, and the dissolution was calculated by external standard method.Results Compared with the Pharmacopoeia method,the dissolution rate was consistent with the limit of 80%,meeting the limit requirement. Conclusion This method can be used as a quality control method for dissolution of clarithromycin tablets.
作者
张丽琴
梅群
肖植国
吕晋
ZHANG Li-qin;MEI Qun;XlAO Zhi-guo;LV Jin(Food and Drug Inspection and Testing Center,Qujing 655000,Yunnan,China)
出处
《医学信息》
2018年第16期126-127,130,共3页
Journal of Medical Information
关键词
克拉霉素
高效液相色谱法
溶出度
标准优化
Clarithromycin
High performance liquid chromatography
Dissolution
Standard optimization