HPLC法测定阿奇霉素糖浆剂中阿奇霉素的含量

Determination of azithromycin in azithromycin syrup by HPLC

目的建立用高效液相色谱法（HPLC）测定阿奇霉素糖浆含量，并与微生物检定法测定结果进行比较。方法采用C18色谱柱（250mm×4．6mm，5μm），以0．067mol·L^-1磷酸二氢钾溶液（用三乙胺调节pH值至6．5）-乙腈（60：40）为流动相；检测波长为210nm，流速为1．0ml·min^-1，柱温45℃。结果阿奇霉素在0．5-5．0g·L^-1浓度范围内呈良好线形关系。平均回收率99．8％，RSD为0．45％；精密度RSD为0．57％（n=5）。结论本法快捷简便，准确可靠，灵敏度高，可用于阿奇霉素糖浆的质量控制。与微生物检定法测定结果进行比较无显著性差异。

Aim To build a method of HPLC for measuring the content of azithromycin syrup and compare it with microbiological assay. Method A C18 （250 mm×4.6mm,5 μm） column was used and the flow phase was acetonitrile -0. 067 mol · L^-1 K2 HPO3 （pH adjusted to 6.5 ） （40 ： 60）. The flow rate was 1.0 ml ·min^-1 , the inflow being 20 μl. The detection wavelength was set at 210 nm, and column temperature was 45 ℃. Results The concentration and peak area of azithromycin syrup have a good linear relationship （ r = 0.999 8 ） within the range of 0.5 - 5.0 g ·L^-1. The recovery ratio was 99.8% ,with an RSD of 0.45%. The precision was 0.57%. Conclusion The method is simple and convenient, quick and precise, which can be used for the quality control of azithromycin syrup. There is no significant difference in results between HPLC and microbiological assay.