复方奥硝唑乳剂的含量测定

Determination of Compound Ornidazole Emulsion by HPLC

目的:采用高效液相色谱法(HPLC法)测定复方奥硝唑乳剂中奥硝唑和酮康唑的含量。方法:色谱柱为C18柱(4.6mm×250mm,5μm),流动相为甲醇-水(74∶26),流速为1.00mL/min,检测波长为239nm。结果:奥硝唑在28～140μg/mL、酮康唑在42.4～212μg/mL范围内浓度与峰面积呈线性关系。奥硝唑的平均回收率为98.62%,RSD=0.52%(n=4);酮康唑的平均回收率为98.98%,RSD=0.21%(n=4)。结论:该法可同时测定两种成分的含量,简便、迅速,适用于医院制剂分析。

Objective:Ornidazole and ketoconazole in compound ornidazole emulsion w ere determined with HPLC method.Methods:HPLC method was used with a column of C1 8(4.6 mm×250 mm,5 μm).The mobile phase was CH3OH-H2O(74 ∶26).The flow rate wa s 1.00 mL/min;the calibration curves were linear in the range of 28～140 μg/mL for ornidazole and 42.4～212 μg/mL for ketoconazole. Results:The average recove ries of ornidazole were 98.62%,RSD=0.52%(n=4) and ketoconazole were 98.98%,RSD=0 .21%(n=4),respectively.Conclusion:The method was simple and rapid,it can be used for the assay of two components in compound ornidazole emulsion,which is suitab le for the preparation in hospital.