HPLC法测定阿奇霉素胶囊中阿奇霉素的含量

Content Determination of Azithromycin in Azithromycin Capsules by HPLC

目的:建立高效液相色谱法测定阿奇霉素胶囊中阿奇霉素的含量。方法:采用Shodex Asahipak ODP-504D色谱柱(150 mm×4.6 mm,5μm);以磷酸盐缓冲液(取磷酸氢二钾6.7 g,加水1000 mL使溶解,混匀)-乙腈(40∶60),用10 mol/L氧化钾溶液调节pH值至(11.0±0.1)为流动相。流速为1.0 mL/min;柱温:40℃;进样体积:10μL;检测波长为210 nm。结果:阿奇霉素在0.0496~0.9697 mg/mL范围内线性关系良好,线性方程为Y=921802X-9915.3(r=0.9999);阿奇霉素平均回收率为为99.85%,RSD值为0.84%。结论:该方法灵敏、简便、重复性好,可用于阿奇霉素胶囊的含量测定。

Objective:To establish a HPLC method for determining the content of azithromycin in azithromycin capsules.Methods:Chromatographic conditions were as follows:Shodex Asahipak ODP-504D column(150 mm×4.6 mm,5μm),phosphate buffer(6.7g of dipotassium hydrogen phosphate,add 1000mL of water to dissolve and mix well)-acetonitrile(40∶60),and adjust the pH value to(11.0±0.1)with 10 mol/L potassium oxide solution as the mobile phase;column temperature 40℃,the flow rate was 1.0 mL/min,the injection volume 10μL,Detection wavelength 210 nm.Results:Azithromycin showed a good linear relationship Y=921802X-9915.3(r=0.9999)with the range of 0.0496~0.9697 mg/mL,the Azithromycin average recovery of it was 99.85%with RSD 0.84%.Conclusion:This method was sensitive,simple and reproducible,which could provide a reference for determining the Azithromycin in Azithromycin Capsules.