阿奇霉素眼用即型凝胶含量及有关物质的测定方法

摘要

OBJECTIVE To establish a HPLC method for the determination of Azithromycin and related sub-stances in Azithromycin in situ gelatin for ophthalmic.METHODS The analysis was carried out with Kromasil C8 column (250mm ×4.6mm,5μm),using acetonitrile-phosphate buffer (50:50).The flow rate was 1.0mL・ min -1, and detection wavelength was set at 210nm.RESULTS The data showed that this method can clearly separate Az-ithromycin from its nearby impurity,the linear range of Azithromycin was 0.4~1.6mg・ mL-1 ,the correlation coeffi-cient was 0.9998 and the average recoveries( n=9) was 99.3%.CONCLUSION The method is simple,specific and accurate,so it can be used for the quality control of this preparation.%目的：建立阿奇霉素眼用即型凝胶含量及有关物质的高效液相色谱检测方法。方法采用 Kromasil C8色谱柱（250mm ×4．6mm，5μm），流动相为乙腈－磷酸盐缓冲液（50∶50），流速为1．0mL・ min －1，检测波长210nm。结果阿奇霉素与其相邻杂质峰能完全分离，在0．4～1．6mg・ mL －1范围内线性关系良好（r＝0．9998）；平均回收率（n＝9）为99．3％。结论所提出的检测方法操作简便、专属性强、结果准确可靠，可用于该制剂的质量控制。