摘要
目的 建立用HPLC分离测定阿奇霉素的含量及其相关物质的方法。方法 采用LunaC18(2 ) 柱 ,以甲醇 水 ( 92∶8)为流动相 ,检测波长 2 15nm ,外标法测定含量 ,面积归一化法测定相关物质。结果 线性范围 9.3~ 4 1.9mg/mL(r =0 .99992 ) ,重复性试验的相对标准偏差小于 1.0 %。结论 方法简便、快速、准确 ,适用于阿奇霉素的质量检查。
OBJECTIVE To develop a HPLC method for the determination of azithromycin and its related substances. METHOD Chromatographic condition included LunaC 18(2) column and the mobile phrase consisted of methanol water(92∶8). The detection wavelength was at 215nm. RESULTS The number of theoretical plates calculated for azithromycin peak was 3000. The linearity ranges were 9.3~41.9mg/mL, r =0.9999; the RSD of the repeatability test was not more than 1.0%. CONCLUSION This method is simple, rapid, accurate and practicable for the quality control of azithromycin.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2003年第5期395-397,共3页
Chinese Journal of Modern Applied Pharmacy