阿奇霉素滴眼液有关物质检查方法的研究

Determination of related substance of Azithromycin Ophthalmic Solution by HPLC

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。

Objective To establish an HPLC method for the determination of the related substance of Azithromycin oph- thalmic solution. Methods Capcell pak C18 MG Ⅱ S5 column（4.6 mm × 150 mm,5μm）was used and the column tempera- tures was 30℃. The flow phase consisted of phosphate buffer solution （0.05 mol·L -1 dipotassium phosphate solution, adjus- ted 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 300mg · 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.