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目的建立一种高效液相色谱法同时测定阿奇霉素滴眼液中阿奇霉素及苯扎氯铵的含量。方法采用十八烷基硅烷键合硅胶色谱柱(4.6 mm×150 mm,5μm),柱温30℃,以乙腈-磷酸盐缓冲液(取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;检测波长210 nm;流速:1.0 mL.min-1。结果阿奇霉素在1.002 8～5.014 0 mg.mL-1的浓度范围内,苯扎氯铵在6.15μg.mL-1～14.35μg.mL-1的浓度范围内均呈线性。阿奇霉素的平均回收率100.68%,RSD为0.50%(n=9);苯扎氯铵的平均回收率100.59%,RSD为0.92%(n=9)。阿奇霉素与苯扎氯铵的定量限分别为750 ng.mL-1、46 ng.mL-1,平均含量分别为106.94%及100.04%,RSD分别为0.94%及0.67%。仪器重复性RSD值均在2.0%以下。结论本方法简单、准确,可同时测定样品中阿奇霉素及苯扎氯铵的含量。
Objective To establish a HPLC method for the simultaneous determination of azithromycin and benzalkonium chloride in azithromycin eye drops. Methods The octadecylsilane bonded silica gel column (4.6 mm × 150 mm, 5 μm) was used. The column temperature was set at 30 ℃. The sample was eluted with acetonitrile-phosphate buffer (0.05 mol·L-1, % Phosphoric acid to adjust the pH to 8.2) (58:42) as the mobile phase; detection wavelength 210 nm; flow rate: 1.0 mL.min-1. Results Azithromycin was linear in the concentration range of 6.15μg.mL-1 ~ 14.35μg.mL-1 in the concentration range of 1.002 8 ~ 5.014 0 mg.mL-1. The average recovery of azithromycin was 100.68% with RSD of 0.50% (n = 9). The average recovery of benzalkonium chloride was 100.59% with RSD of 0.92% (n = 9). The limits of quantitation for azithromycin and benzalkonium chloride were 750 ng.mL-1, 46 ng.mL-1, respectively. The average contents of azithromycin and benzalkonium chloride were 106.94% and 100.04%, respectively, with RSDs of 0.94% and 0.67%, respectively. Instrument repeatability RSD values are below 2.0%. Conclusion This method is simple and accurate, and can simultaneously determine the azithromycin and benzalkonium chloride content in the sample.