高效液相色谱法测定阿奇霉素干混悬剂中阿奇霉素的含量

Content Determination of Azithromycin Suspension by HPLC

目的:建立高效液相色谱法测定阿奇霉素干混悬剂含量的方法。方法:Venusil XBP-C18(L)(150mm×4.6mm,5μm)柱为固定相,0.05mol·L-1磷酸氢二钾(20%的磷酸溶液调节pH值至8.2)-乙腈(45∶55)为流动相,进样量为20μL,流速为1.2mL·min-1,紫外检测波长为210nm。结果:阿奇霉素主成分峰与相邻杂质峰分离度>1.5。阿奇霉素检测浓度在10～5000μg·mL-1内与峰面积积分值呈良好线性关系(r=0.9999);平均回收率为98.83%,RSD=0.54%(n=6),日内、日间与中间精密度均<2.5%。结论:本法专属性强、准确,可用于测定阿奇霉素干混悬剂的含量。

OBJECTIVE：To establish the HPLC method for content determination of Azithromycin suspension.METHODS：The determination was performed on Venusil XBP-C18（L） （150 mm×4.6 mm,5μm） column with mobile phase consisted of 0.05 mol·L-1 dipotassium phosphate （pH value adjusted to 8.2 by 20% phosphoric acid）-acetonitrile （45：55） at flow rate of 1.2 mL·min-1.Injection volume was 20 μL and UV detection wavelength was set at 210 nm.RESULTS：The good resolution between peaks of azithromycin and that of adjacent purity was more than 1.5.The linear range of azithromycin was 0.01～5 mg·mL-1 （r= 0.999 9） with an average recovery of 98.83%（RSD=0.54%,n=6）.The precision of intra-day,inter-day and with-day were all lower than 2.5%.CONCLUSION：The method is specific and accurate for the content determination of Azithromycin suspension.