高效液相色谱法测定更昔洛韦缩合物中基因毒性杂质  

Determination of Genotoxic Impurities in Ganciclovir Condensates by HPLC

作　　者：王建 曹丽 吴柯 许雨恬 范华玉 Wang Jian;Cao Li;Wu Ke;Xu Yutian;Fan Huayu(Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,Ltd.,Changzhou 213105,China)

机构地区：[1]上药康丽(常州)药业有限公司,江苏常州213105

出　　处：《山东化工》2021年第24期119-121,124,共4页Shandong Chemical Industry

摘　　要：目的:建立高效液相色谱方法测定更昔洛韦缩合物中2种潜在基因毒性杂质对甲苯磺酸甲酯和对甲苯磺酸乙酯。方法:采用Agilent Eclipse plus C 18色谱柱(250 mm×4.6 mm,5μm),以0.1%磷酸水溶液为流动相A,乙腈为流动相B进行等度洗脱用二极管阵列检测器在检测波长225 nm处检测2种目标物。结果:2种目标物在一定质量浓度范围内均与其对应的峰面积呈线性关系,检出限(3S/N)分别为15.852,15.848 ng·mL^(-1);对实际样品进行加标回收试验,所得回收率分别为101.3%~106.0%,103.1%~106.7%。结论:本方法适用于样品更昔洛韦缩合物中对甲基苯磺酸甲酯和对甲基苯磺酸乙酯的检测。Objective:To establish a HPLC method for the determination of two potential genotoxic impurities methyl toluenesulfonate and ethyl toluenesulfonate in ganciclovir condensates.Methods:Agilent Eclipse Plus C 18 column(250 mm×4.6 mm,5μm)was used with 0.1%phosphoric acid aqueous solution as mobile phase A and acetonitrile as mobile phase B.Diode array detector was used to detect the two targets at the detection wavelength of 225 nm.Results:There was a linear relationship between the peak areas of the two kinds of target substances in a certain range of mass concentration,and the detection limits(3S/N)were 15.852 and 15.848 ng·mL^(-1),respectively.The recoveries of actual samples were 101.3%~106.0%and 103.1%~106.7%,respectively.Conclusion:This method is suitable for the determination of methyl p-methylbenzenesulfonic acid and ethyl p-methylbenzenesulfonic acid in ganciclovir condensates.

关 键 词：高效液相色谱法 更昔洛韦缩合物 基因毒性 对甲苯磺酸甲酯 对甲苯磺酸乙酯 

分 类 号：TQ460[化学工程—制药化工] O657.7[理学—分析化学]