HPLC与微生物检定法测定阿奇霉素滴眼液含量的比较研究

目的运用微生物检定法与HPLC法测定阿奇霉素滴眼液的含量,并比较其适用性。方法不同时间点抽取3个批号的阿奇霉素滴眼液,同时采用微生物检定法与HPLC进行检测阿奇霉素质量浓度。微生物检定法参照中国药典2005年版;HPLC法采用反相ODS-C18柱色谱柱,流动相为乙-腈0.1 mol·L-1磷酸二氢钾水溶液(30∶70),流速为0.5 mL·min-1,柱温40℃,紫外检测波长为215 nm。结果室温留样观察12个月,经抗生素微生物检定法(效价法)检测,阿奇霉素滴眼液中阿奇霉素含量下降了8.53%~12.39%;经HPLC检测,阿奇霉素含量下降了17.29%~23.50%。结论高效液相色谱法与微生物检定法相比差异较大,前者只适用于阿奇霉素的检定,微生物检定法更能准确的反映阿奇霉素滴眼液的抗菌活性,在应用时应根据具体情况选择合适的检定方法。

Comparison of HPLC and microbiological methods in the detection of azithromycin in eye drops

Objective To compare HPLC and microbiological methods in the detection of azithromycin in eye drops.Method Three batches Azithromycin eye drops were detected by HPLC and microbiological methods in different time point.The microbiological method was the method collected in Ch.P（2005）;The HPLC method was as follows：the samples were separated by ODS-C18 column（150 mm×4.6 mm,5 μm）with acetonitrile and 0.1 mol·L-1 KH2PO4 as the mobile phase（30∶70） at 40 ℃,the flow rate was 0.5 mL·min-1 and detected at 215nm.Results After 12 months in room temperature,the content of azithromycin in eye drops was decreased 8.53%~12.39% by microbiological method,and 17.29%~23.50% by HPLC method.Conclusion The HPLC and microbiological methods showed significant difference in the detection of azithromocin.The HPLC method is suitable for detecting azithromocin;the microbiological method is suitable for the detecting the antibacterial activity of azithromycin eye drops.We should select the appropriate test methods under the specific circumstances in the application.