HPLC法分析注射用乳糖酸阿奇霉素的有关物质和含量  

Determination of the Content and Related Substances in Azithromycin Lactobionate for Injection by HPLC

作　　者：赵沈娟[1] 宋雪洁[1] 陈琴华[1] 朱佳丽[1] 

机构地区：[1]扬子江药业集团质量管理部,江苏泰州225321

出　　处：《中国药师》2012年第8期1142-1145,共4页China Pharmacist

摘　　要：目的:建立一种能用于注射用乳糖酸阿奇霉素中有关物质和含量控制的HPLC方法。方法:采用CAPCELL PAK C18(MGⅡ)柱(150 mm×4.6 mm,5μm),柱温30℃,流动相为磷酸盐缓冲液(0.05 mol.L-1磷酸氢二钾溶液,磷酸调pH至8.4±0.1)-乙腈(45∶55),流速1.0 ml.min-1,检测波长210 nm。结果:有关物质与主成分阿奇霉素能达到基线分离;酸根对有关物质的测定无影响;阿奇霉素在0.469 0～1.407 0 mg.ml-1范围内线性关系良好(r=0.999 5),平均回收率98.6%(n=6),RSD为0.4%。结论:该法简便,准确,其他组分不干扰测定,可用于本品的质量控制。Objective： To established an HPLC method for the determination of the content and related substances in azithromycin lactobionate for injection. Method： A CAPCELL PAK C18 （ MG 11 ） column. （ 150 mm × 4.6 mm,5 μm） was used and the column temperature was 30℃. The mobile phase was phosphate buffer solution （ adjusting pH to 8.4±0.1 with phosphoric acid ） -acetonitrile （45 ：55）. The flow rate was 1.0 ml ·min -1 and the detection wavelength was 210 nm. Result： Azithromycin and its related substances could be well separated using the developed system. The acidic groups in azithromycin lactobionate for injection did not interfere with the determination of the related substances. The linear range of azithromycin was 0.469 0-1. 407 0 mg ·ml-1 The average recovery was 98.6% （RSD =0.4%, n = 6）. Conclusion： The method is convenient and accurate without interference, and suitable for the quality control of azithromycin lactobionate for injection.

关 键 词：高效液相色谱法 注射用乳糖酸阿奇霉素 有关物质 含量 

分 类 号：R927.2[医药卫生—药学]