作　　者： (徐靖）; (过芳）; (宋丹）; (管海燕）;

机构地区： 第三军医大学大坪医院,重庆400042

出　　处： 《儿科药学杂志》 2017年第9期41-44,共4页

摘　　要： 目的:建立高效液相色谱(HPLC)法测定氟哌噻吨美利曲辛片有效成分的含量并控制杂质。方法:色谱柱为C18(150 mm×4.6 mm,5μm);流动相为甲醇-0.2%磷酸(含0.1%三乙胺)(65∶35);流速1.0 mL/min,柱温30℃,检测波长257 nm,进样量20μL。结果:美利曲辛测得含量为标示量的98.89%,线性浓度范围20~240μg/mL,低、中、高浓度供试品的平均回收率分别为102.8%、99.5%、99.5%;氟哌噻吨测得含量为标示量的96.17%,线性浓度范围10~100μg/mL,低、中、高浓度供试品的平均回收率分别为100.1%、101.8%、100.2%。杂质总量与美利曲辛含量的百分比<1.0%。结论:该方法灵敏、准确、专属性强,可用于氟哌噻吨美利曲辛片的质量控制。 Objective：To develop a HPLC method to determinate the active constituent content of flupentixol melitracen tablet.Methods：Diamonsil technology C_（18） column（150 mm×4.6 mm,5 μm） was used with methanol -0.2% phosphoric acid（including 0.1% triethylamine）（65∶35） as the mobile phase at a flow rate of 1.0 mL/min.Column temperature was 30 ℃.Detected wavelength was 257 nm.Results：Melitracen content was 98.89%,linear range was 20~240 μg/mL,the average recoverys of low,middle and high concentration were 102.8%,99.5%,99.5%.Flupentixol content was 96.17%,linear range was 10~100 μg/mL,the average recoverys of low,middle and high concentration were 100.1%,101.8%,100.2%.The impurity amount in melitraven was not greater than 1.0%.Conclusion：The results demonstrated this method is sensitive,accurate,precise and specific for the determination of the contents and relative substances.It is useful for the quality control of flupentixol melitracen tablet.

关 键 词： 氟哌噻吨 美利曲辛 含量测定 质量标准 高效液相色谱