RP-HPLC法同时测定复方氟康唑霜中氟康唑、甲硝唑、氯霉素3种组分含量

Determination of Fluconazole, Metronidazole, Chloramphenicol in Compound Fluconazole Cream by RP-HPLC

目的： 建立同时测定复方氟康唑霜中氟康唑、甲硝唑、氯霉素３ 组分含量的简便方法。方法： 反相高效液相色谱法， 采用外标法， Ｕｌｔｒａｓｐｈｅｒｅ－ ＯＤＳ柱， 流动相为甲醇－ 水（５０∶５０） ， 检测波长２６１ ｎｍ 。结果： 线性范围分别是： 氟康唑４０－１ ～２００－６ μｇ·ｍＬ－１ ， ｒ＝０－９９９ ４； 甲硝唑２０－０ ～１００－０ μｇ·ｍＬ－１ ， ｒ＝０－９９９ ８； 氯霉素３９－９～１９９－６ μｇ·ｍＬ－ １ ， ｒ＝ ０－９９９ ８。平均回收率： 氟康唑９８－３１ ％ ； 甲硝唑１００－４ ％ ， 氯霉素９８－１７ ％ 。结论：本法分离度好， 快速， 简便。适用于该制剂中３ 种成分的同时测定。

Objective:To establish a method for determination of the three constituents in compound Fluconazole cream: Fluconazole, Metronidazole, Chloramphenicol.Method:RP-HPLC was applied to quantitative analysis. Ultrasphere-ODS column was used. The mobile phase was composed of methanol-water(50∶50). The UV detection wave length was 261 nm. Results:The linear response range from 40 1～200 6 μg·mL -1 of Fluconazole( r =0 999 4).20 0～100 0 μg·mL -1 of Metronidazole( r =0 999 8).39 9～199 6 μg·mL -1 of Chloramphenicol( r =0 999 8). The mean recoveries of Fluconazole, Metronidazole, Chloramphenicol were 98 31%, 100 4%, 98 17%. Conclusion:The method is simple, sensitive and suitable for the determination of the three constituents in compound cream.