改进高效液相色谱法测定氯霉素滴耳液及其相关物质二醇物的含量

目的建立以改进的高效液相色谱法（HPLC）分离测定氯霉素滴耳液的含量,并对其中降解产物二醇物进行控制。方法固定相为KromasilC18色谱柱（4.6mm×250mm,5μm）,流动相为甲醇-乙腈-0.15%磷酸（1∶3∶5）;流速为1.0ml/min,柱温：35℃,检测波长为270nm。结果氯霉素的平均回收率为99.61%,RSD为0.46%。氯霉素二醇物的平均回收率为99.41%,RSD为0.77%。结论该法可同时测定氯霉素滴耳液中氯霉素与氯霉素二醇物的含量,而且快速、准确、简便、灵敏度高、分离度好。

Improvement HPLC method to determination the content of chloramphenicol ear drops and its related substances

Objective To establish an improvement HPLC method for determ ination the content of chloramphenicol ear drops,and to control the degradation products of glycols. Methods The fixed phase was Kromasil C18 column（ 4. 6mm × 250mm,5μm） ,mobile phase consisted of methanol-acetonitrile-0. 15% phosphoric acid（ 1∶3∶5） ; The flow rate was 1. 0ml/ min,the column temperature was 35℃,the detection wavelength was set at 270nm. Results The average recovery of chloramphenicol was 99. 61,RSD = 0. 46%. The average recovery of chloramphenicol glycols was 99. 41% ,RSD = 0. 77%. Conclusion This method can be used for the simultaneous determination of chloramphenicol content and chloramphenicol glycols content in chloramphenicol ear drops,and it has the character of fast,accurate,simple,highly sensitive and good separation.