摘要
目的:建立测定注射用乳糖酸阿奇霉素含量的HPLC法。方法:Dikma Diamonsil^(TM)C_(18)柱(250 mm×4.6 mm,5μm),流动相为0.05 mol·L^(-1)磷酸二氢铵溶液(三乙胺调节pH至7.0)-乙腈-水(10:35:55),流速为1.0 ml·min^(-1),检测波长为215 nm,柱温为40℃。结果:阿奇霉素的线性范围为99.76～4988.0μg·ml^(-1),平均回收率为102.0%,RSD=1.0%(n=6)。结论:HPLC法简便,准确,其他组分不干扰测定,可用于本品的质量控制。
Objective： To established a HPLC method for determination the content of Azithromycin in Azithromycin Lactobionate for Injection. Method： Dikma Diamonsil^TM C18 column （250 mm×4.6 mm, 5 μm） was used. The mobile phase was 0.05 mol·L^-1 Ammonium phosphate monobasic solution（ adjusted to pH 7.0 with Triethylamine）-Acetonitrile-water（ 10： 35：55 ）. The flow rate was 1.0 ml·min^-1 and the detection wavelength was 215 nm. Result： The linear range of Azithromycin was 99.76 -4988.0μg·ml^-1. The average recovery was 102.0% （RSD = 1.0%, n = 6）. Conclusion： This method is convenient, accurate without interference and is suitable for the quality control of Azithromycin Lactobionate for Injection.
出处
《中国药师》
CAS
2007年第11期1067-1069,共3页
China Pharmacist
