HPLC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

Determination of azithromycin and benzalkonium chloride in Azithromycin Eye Drops by HPLC

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 an HPLC method for the determination of azithromycin and benzalkonium chloride in Azithromycin Eye Drops.Methods C18 column（4.6 mm×150 mm,5 μm） was used and the column temperatures was 30 ℃.The mobile phase consisted of phosphate buffer solution（0.05 mol·L-1 dipotassium phosphate solution,adjusted pH to 8.2 by 20% phosphoric acid solution）-acetonitrile（58∶42）.The detection wavelength was 210 nm and the flow rate was 1.0 mL·min-1.Results The linear ranges of azithromycin and benzalkonium chloride were 1.00 28～5.014 0 mg·mL-1 and 6.15～14.35 μg·mL-1,with average recoveries of 100.68% and 100.59%,RSD of 0.50%（n=9） and 0.92%（n=9）,respectively.The LOQ of azithromycin and benzalkonium chloride were 750 ng·mL-1 and 46 ng·mL-1,the average contents were 106.94% and 100.04% and the RSD were 0.94% and 0.67%,respectively.The RSD of repeatability was under 2.0%.Conclusion This method was simple and accurate,and it can be used for the determination of azithromycin and benzalkonium chloride in Azithromycin Eye Drops.