氯霉素滴眼液及其相关物质二醇物的毛细管电泳分析法

Determination of Chloramphenicol Eyedrop and Its Related Impurity

目的 建立适合氯霉素滴眼液含量测定及其杂质二醇物检测的高效毛细管电泳定量检测方法。 方法 采用毛细电泳法 ,以水杨酸为内标 ,运行电压 2 5 KV,运行缓冲液为 2 5 mmol· L- 1 磷酸盐缓冲液 (p H=6.0 ) ,检测波长 2 14 nm。结果 氯霉素滴眼液及二醇物线性范围分别为 5 0～ 2 5 0 μg·ml- 1 (r=0 .9992 )和 4.0～ 2 0 .0 μg· ml- 1 (r=0 .9988)。平均回收率分别为 99.8%和 10 1.5 % ,RSD分别为 0 .8%和 2 .0 % (n=5 )。结论 本方法能同时进行含量测定和杂质检测 。

OBJECTIVE To establish a high performance capillary electrophoresis(HPCE)method for determination of Chloramphenicol Eyedrop and its related impurity 1 p nitrophenyl 2 amino 1.3 propanediol by zone electrophresis.METHODS Salicylic acid was used as internal with the running buffer of 25mmol·L -1 phosphate(pH6.0),the running voltage was 25kv,at the detection wavelength of 214nm.RESULTS The linear range of and Chloramphenicol and 1 p nitrophenyl 2 amino 1.3 propanediol were 50～250μg·ml -1 (r=0.9992) and 4 0～20 0μg·ml -1 (r=0.9988),respectively.The average recoveries were 99.8%(RSD=0.8%) and 101.5%(RSD=2.0%),respectively.CONCLUSION The method can be used to control the qualily of Chloramphenicol Eyedrop.