阿奇霉素滴眼液有关物质检查方法的研究

目的建立高效液相色谱法测定阿奇霉素有关物质的方法。方法采用硅胶表面经杂化处理的十八烷基硅烷键合硅胶色谱柱Capcell pak MGⅡ(4.6 mm×150 mm,5μm),柱温30℃,以乙腈-磷酸盐缓冲液(0.05 mol.L-1磷酸氢二钾溶液,用20%磷酸调节pH至8.2)(58∶42)为流动相,流速为1.0 mL.min-1,检测波长为210nm。结果阿奇霉素的检测限及定量限分别为300、750 ng.mL-1;阿奇霉素与杂质峰及各杂质峰之间能够有效分离;阿奇霉素在60.2～180.6μg.mL-1范围内线性良好;供试品溶液在8 h内稳定性良好。结论本方法科学、简单、准确,适用于阿奇霉素滴眼液的有关物质检查。

Determination of related substance of Azithromycin Ophthalmic Solution by HPLC

Objective To establish an HPLC method for the determination of the related substance of Azithromycin ophthalmic solution.Methods Capcell pak C18 MG Ⅱ S5 column(4.6 mm×150 mm,5 μm)was used and the column temperatures was 30 ℃.The flow phase consisted of phosphate buffer solution(0.05 mol·L-1dipotassium phosphate solution,adjusted pH to 8.2 by phosphoric acid)-acetonitrile(58∶ 42).The flow rate was 1.0 mL·min-1.The detection wavelength was 210 nm.Results The LOD and LOQ of azithromycin were respectively 300 ng·mL-1 and 750 ng·mL-1.Good separation was achieved between azithromycin and the related substance.The linearity of azithromyc was obtained in the range of 60.2~180.6 μg·min-1.The sample solution was stable in 8 h.Conclusion This method was scientific,simple and accurate,and it was suitable for the determination of the related substance of Azithromycin Ophthalmic Solution.