HPLC法测定注射用乳糖酸阿奇霉素的有关物质  

Determination of Related Substances in Azithromycin Lactobionate for Injection by HPLC

作　　者：潘强[1] 王绪 杨雪 王洋[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]抚顺市食品药品检验所 [3]辽宁富东制药有限公司

出　　处：《中国药师》2013年第3期371-373,375,共4页China Pharmacist

摘　　要：目的:建立高效液相色谱法测定注射用乳糖酸阿奇霉素的有关物质。方法:采用XBridge Shield RP18柱(250 mm×4.6 mm,5μm),柱温40℃,流动相A为0.01 mol·L^(-1)无水水磷酸氢二钠溶液(用稀磷酸调节pH至8.9),流动相B为甲醇-乙腈(250:750),梯度洗脱,流速为1.0 ml·min^(-1);检测波长210 nm。结果:阿奇霉素在2.017～30.255μg·ml^(-1)范围内线性关系良好(r=0.999 9)。阿奇霉素与其降解产物在该色谱条件下能够有效分离,检测限为0.11μg·ml^(-1)。结论:该方法简便、快速、灵敏、准确,可用于测定注射用乳糖酸阿奇霉素的有关物质。Objective：To establish a method for the determination of the related substances in azithromycin lactobionate for injection by HPLC.Method：The analysis was performed on an XBridge Shield RP18（250 mm×4.6 mm,5μm）column,the column temperature was 401,the mobile phase A was 0.01 mol·L^（-1） anhydrous disodium hydrogen phosphate solution（adjusting pH to 8.9 with dilute phosphoric acid） and the mobile phase B was composed of methanol-acetonitrile（250：750） with gradient elution at the flow rate of 1.0 ml·min^（-1）.The detection wavelength was 210 nm.Result：The linear range of azithromycin was 2.017-30.255μg·ml^（-1）（r = 0.999 9）.Azithromycin and its related substances could be separated completely using the developed system.The limit of detection was 0.11μg·ml^（-1）.Conclusion：The method is simple,quick,sensitive,and accurate,and can be used to determine the related substances in azithromycin lactobionate for injection.

关 键 词：阿奇霉素 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]