RP-HPLC法测定阿奇霉素颗粒(Ⅱ)中主药的含量

Content Determination of Azithromycin Granules(Ⅱ)by RP-HPLC

目的：建立测定阿奇霉素颗粒（Ⅱ）中主药含量的方法。方法：采用反相高效液相色谱法。色谱柱为Agilent ZORBAX Extend-C18柱,流动相为磷酸盐缓冲液（取0.05 mol/L磷酸氢二钾溶液,用20%的磷酸溶液调节pH至8.2）-乙腈（45∶55,V/V）,检测波长为210 nm,流速为1.0 ml/min,进样量为20μl,柱温为30℃。结果：阿奇霉素检测质量浓度在0.259~2.586 mg/ml范围内与峰面积积分值呈良好的线性关系（r=0.999 8）;精密度、稳定性、重复性试验的RSD均≤1.0%;平均加样回收率为100.2%,RSD=0.5%（n=9）。结论：该方法简便、快速、准确,可用于该制剂的质量控制。

OBJECTIVE：To establish a method for the content determination of Azithromycin granules（Ⅱ）.METHODS： RP-HPLC was adopted.The determination was performed on Agilent ZORBAX Extend-C18 column with mobile phase consisted of phosphate buffer solution（0.05 mol/L dipotassium hydrogen phosphate solution,adjusting pH to 8.2 with 20% phosphoric acid）-acetonitrile（45∶55,V/V）at the flow rate of 1.0 ml/min.The detection wavelength was set at 210 nm and the column temperature was 30 ℃.The sample size was 20 μl.RESULTS：The linear range of azithromycin was 0.259-2.586 mg/ml（r=0.999 8）with an average recovery of 100.2%（RSD=0.5%,n=9）.CONCLUSIONS：The method is simple,rapid and accurate for quality control of the preparation.