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目的:建立测定纤维蛋白胶阿奇霉素复合体中阿奇霉素含量的高效液相色谱法。方法:采用安捷仑ZORBAX Stable Bound(250 mm×4.6 mm,5.0μm)色谱柱,流动相:乙腈-磷酸缓冲盐溶液(pH=4)(28∶72),流速:1.0 ml·min~(-1),检测波长:215 nm,柱温:45℃。结果:阿奇霉素在0.99~29.85μg范围内具有良好的线性关系(r=0.999 9),平均回收率为100.7%(RSD=3.92%,n=9)。结论:本方法准确可靠,简便易行,可用于相关制剂中阿奇霉素的含量测定。
Objective: To establish a HPLC method for the determination of azithromycin in fibrin glue azithromycin complex. METHODS: The mobile phase consisted of acetonitrile-phosphate buffered saline (pH = 4) (28:72), flow rate of 1.0 ml · min ~ (-1) with ZORBAX Stable Bound (250 mm × 4.6 mm, -1), detection wavelength: 215 nm, column temperature: 45 ℃. Results: Azithromycin has a good linear relationship (r = 0.999 9) in the range of 0.99 ~ 29.85 μg with an average recovery of 100.7% (RSD = 3.92%, n = 9). Conclusion: The method is accurate and reliable, simple and easy to use, and can be used for the determination of azithromycin in related preparations.