摘要
目的:建立注射用阿奇霉素枸橼酸二氢钠含量和有关物质的测定方法。方法:采用高效液相色谱法,并与该制剂标准采用的含量测定方法(抗生素微生物检定法)及有关物质检查方法(薄层色谱法)测定结果进行比较。色谱柱为资生堂C18MGⅡ柱,流动相为磷酸盐缓冲液(pH8.2)-乙腈(45:55,V/V),流速为1.0ml/min,检测波长为215nm,柱温为35℃。结果:阿奇霉素检测质量浓度线性范围为0.5～3.0mg/m(lr=0.9999),平均回收率为100.2%,RSD=0.7%(n=9)。本方法主药含量测定结果与原标准方法结果一致,有关物质检查方法优于原标准方法。结论:建立的方法简便、准确、专属性强、重复性好,可用于注射用阿奇霉素枸橼酸二氢钠含量及有关物质的测定。
OBJECTIVE： To establish a method for the content determination of azithromycin and its related substances in Azithromycin sodium dihydrogen citrate for injection. METHODS： HPLC method was adopted and compared with the results of standard method for content determination of the preparation （antibiotic microbiological assay） and TLC for related substances. The determination was performed on C^8 MG ]I column with mobile phase consisted of phosphate buffer （pH 8.2）-acetonitrile （45：55, V/V） at flow rate of 1.0 ml/min. The detection wavelength was set at 215 nm and column temperature was 35 ℃. RESULTS： The linear range for azithromycin was 0.5-3.0 mg/ml （r=0.999 9） with average recovery of 100.2% （RSD=0.7%, n=9）. The results of content determination of main component are concordant with those of standard method. The method for the determination of re- lated substance was better than previous method. CONCLUSIONS： The method is simple, accurate, specific and reproducible, and suitable for the content determination of azithromycin and its related substances in Azithromycin sodium dihydrogen citrate for injec- tion.
出处
《中国药房》
CAS
CSCD
2013年第5期450-452,共3页
China Pharmacy
