HPLC法测定阿奇霉素干混悬剂中阿奇霉素的含量

目的：建立高效液相色谱法测定阿奇霉素干混悬剂中阿奇霉素含量的方法。方法采用 XTerra RP C18柱（4.6×150mm，5μm）为固定相，以0.075mol· L -1磷酸二氢铵（三乙胺调节pH至6.5）-乙腈（70∶30）为流动相，进样量为25μL，流速为1.0mL· min -1，柱温30℃，紫外检测波长为205nm。结果阿奇霉素检测浓度在0.05～3.20mg· mL -1范围内与峰面积呈良好的线性关系（ r＝0.9995）；平均回收率为100.3％， RSD＝0.177％（n＝9），精密度＜1.0％。结论测定结果准确可靠，重现性好。与药典法采用的微生物检定法进行比较，测定结果基本一致。

Content Determination of Azithromycin in Azithromycin Suspension by HPLC

OBJECTIVE To establish a HPLC method for content determination of Azithromycin in Azithromy-cin suspension.METHODS The determination was performed on Venusil XTerra RP C18（4.6 ×150mm,5μm）col-umn with mobile phase consisted of 0.075 mol · L-1 ammonium dihydrogen phosphate （ pH value adjusted to 6.5 by triethylamine）-acetonitrile（70∶30）at flow rate of 1.0mL· min-1.Injection volume was 25μL,the column tempera-tures was 30℃and UV detection wavelength was set at 205 nm.RESULTS The linear range of azithromycin was 0.05~3.2mg· mL-1（r=0.9995）with an average recovery of 100.3%（RSD=0.177%,n=9）.The precision was lower than 1.0%.CONCLUSION The determination results are accurate ,reliable and reproducible which are ba-sically identical.with pharmacopoeia method using microbial test method.