HPLC法分析阿奇霉素及各类注射剂中有关物质的含量  

RP-HPLC determination of azithromycin and its related substances in durg substances and parenteral formulation

作　　者：王明娟[1] 许明哲[1] 胡昌勤[1] 王立新[1] 王晨[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国抗生素杂志》2008年第12期740-745,共6页Chinese Journal of Antibiotics

摘　　要：目的建立一种能用于阿奇霉素原料及制剂中有关物质控制的HPLC方法。方法采用XBridge Shield RP18柱(250mm×4.6mm,5μm),柱温30℃,流动相为乙腈∶pH8.2磷酸盐缓冲液(0.05mol/L磷酸氢二钾溶液,用20%磷酸调节pH至8.2)(55∶45),流速1.0ml/min;检测波长210nm;样品溶液的进样量为200μg。结果阿奇霉素与其杂质(氮杂红霉素A,红霉素A肟,N-去甲基阿奇霉素,阿奇霉素德糖胺以及阿奇霉素N-氧化物)能达到基线分离;盐酸、硫酸、乳糖酸、柠檬酸、马来酸等阿奇霉素注射剂中常用酸根对阿奇霉素有关物质的测定无影响;方法的线性、准确性、灵敏度以及粗放性均能满足要求。结论本文所建方法能较好地反映国产各种阿奇霉素原料及制剂中的有关物质的情况,为国内市场上不同阿奇霉素注射剂的评价、阿奇霉素及其口服制剂的质量控制提供了较好的分析手段。Objective To develop an azithromycin in parenteral products. Method HPLC method for determination the related substances of The separation was performed on a column of XBridge Shield RP18 （250mm × 4.6mm, 5μm）, with acetonitrile ： pH8.2 phosphate buffer （0.05mol/L K2HPO4 solution, adjust pH to 8.2 with 20% phosphate acid） （55 ： 45） as the mobile phase at flow rate of 1.0ml/min. The detection wavelength was 210 nm. The injection amounts of sample solutions were 200μg. Result Azithromycin and its related substances, including azaerythromycin A, erythromycin A oxime, N-demethy- lazithromycin, desosaminylazithromycin and azithromycin N-oxide, can be well separated from each other on the developed system. The co-existence acids in azithromycin for injection e.g. HCl, H2SO4, lactobionic acid, maleic acid, citric acid, etc, did not interfere with the determination of the related substances. Linearity, accuracy, sensitivity and robustness of the method could meet the specific analytical requirements. Conclusion The developed method can be successfully applied to the quality control of azithromycin drug substances and products.

关 键 词：阿奇霉素 有关物质 原料 制剂 

分 类 号：R978.15[医药卫生—药品]