作　　者： (张悦杨）; (刘峰）;

机构地区： 四川省食品药品检验检测院,四川成都611731

出　　处： 《四川生理科学杂志》 2017年第3期117-119,共3页

摘　　要： 目的:建立HPLC梯度洗脱法测定利培酮片的有关物质。方法:采用Sepax GP-C18(4.6×100mm,3μm)为色谱柱;以流动相A:水-乙腈-三氟乙酸(80:19.5:0.1)(用氨水调节pH值至3.0)与流动相B:水-甲醇-三氟乙酸(61:39:0.1)(用氨水调节pH值至3.0),进行梯度洗脱;柱温35℃,流速1.0 mL·min^(-1),检测波长275nm。结果:利培酮在0.5088μg·ml^(-1)~1017.6μg·ml^(-1)浓度范围内与相应峰面积线性关系良好;检测限(S/N=3)为0.5088ng·mL^(-1)。结论:优化后的方法更有利于利培酮片杂质的检出。 Objective：To optimize an HPLC method for the determination of the related substances in Resperidone tablets.Methods：Analysis was carried out on a Sepax GP-C18（4.6×100 mm,3 μm）;the column temperature was 35 ℃,the flow rate was 1.0 mL·min^（-1）,the mobile phase A is water-methanol-TFA（89：19.5：0.1）（adding ammonia to adjust the pH to 3.0）,the mobile phase B is water-methanol-TFA（61：39：0.1）（adding ammonia to adjust the pH to 3.0）,the injection volume was 20 μL,and the detection wave length was 275 nm.Results：The linear ranges of Resperidone were 0.5088 μg·ml^（-1）~1017.6 μg·ml^（-1）,respectively.The limits of detection（S/N=3）was 0.5088 ng· mL^（-1）.Conclusion：The optimized method is more propitious to detect the related substances in Resperidone tablets,and control the known impurities.

关 键 词： 利培酮片 高效液相色谱法 有关物质 梯度洗脱