HPLC法测定阿奇霉素干混悬剂的有关物质

目的:建立测定阿奇霉素干混悬剂中有关物质的方法。方法:采用高效液相色谱法。色谱柱为Venusil XBPC18,流动相为0.05 mol·mL-1磷酸氢二钾溶液(20%磷酸调pH=8.2)-乙腈(47∶53),进样量为20μL,流速为1.2 mL·min-1,检测波长为210nm。结果:样品经过光照破坏试验后分离度为1.92,加热破坏试验后分离度为2.16,加酸破坏试验后分离度为1.76,加碱破坏试验后分离度为7.88,氧化破坏试验后分离度为.11。3批样品的有关物质含量分别为2.41%、2.45%、2.43%。结论:本法测定阿奇霉素干混悬剂的有关物质简便、灵敏、准确。

Determination of Related Substances of Azithromycin Suspension by HPLC

OBJECTIVE：To establish a method for the determination of the related substances of Azithromycin suspension.METHODS：HPLC was adopted using Venusil XBP-C18 as column.The mobile phase consisted of 0.05 mol·L-1 dibasicsodium phosphate buffer solution（pH value adjusted to 8.2 by 20% phosphoric acid）-acetonitrile（47：53）.The injection volume was 20 μL and the flow rate was 1.2 mL·min-1.UV detection wavelength was set at 210 nm.RESULTS：The resolution was 1.92 after experimental light damage,and it was 2.16 after heat damage test.After treated with acid,resolution of sample was 1.76,and it was 7.88 and 2.11 in alkali destruction test and oxidative damage test.The related substances were 2.41%,2.45% and 2.43%.CONCLUSION：The method is simple,sensitive and accurate for the determination of the related substances of Azithromycin suspension.