HPLC法测定注射用阿奇霉素磷酸二氢钠的含量及有关物质

Determination of the content and related substances of Azithromycin Sodium Dihydrogen Phosphate for Injection by HPLC

目的建立一种高效液相色谱方法来测定注射用阿奇霉素磷酸二氢钠含量及有关物质。方法以Shi—seidoC18（4．6mm×250mm，5μm）色谱柱为分析柱，以磷酸盐缓冲液（0．05mol·L^-1磷酸氢二钾溶液，用20％磷酸溶液调节pH值至8．2）-乙腈（40：60）为流动相，柱温30℃，检测波长为210nm，流速为1．0mL·mim^-1。结果阿奇霉素在10～5000μg·mL^-1范围内浓度与峰面积呈良好线性关系，r=1．0000，平均回收率为100．6％，RSD为0．99％（n=9）。结论芩方法可快速、准确的测定注射用阿奇霉素磷酸二氢钠含量及有关物质的测定。

Objective To establish an HPLC method for content and related substances determination of Azithromyein Sodium Dihydrogen Phosphate for Injection. Methods A Shiseido C 18 （4. 6 mm × 250mm,5 μm） column was used, the mo- bile phase consisted of 0. 05 mol·L^-1 K2 HPO4 solution （ pH 8.2, adjust with 20% phosphate acid ） - acetonitrile （ 40：60 ）, the column temperature was set at 30 ℃ ,the detection wavelength was 210 nm,the flow rate was 1.0 mL · min^-1. Results The linear range of azithromycin was 10 - 5 000 μg·mL^-1 （ r = 1. 000 0 ） , the average recovery （ n = 9 ） was 100. 6% （ RSD = 0. 99% ）. Conclusion The method can be used for the content and related substances determination of Azithromyein Sodium Dihydrogen Phosphate for Injection.