HPLC法测定巯嘌呤咀嚼片中有关物质  

Determination of Related Substances in Mercaptopurine Chewable Tablets by HPLC

作　　者：沈舒 肖颖倩 赵亚男 徐成 Shen Shu;Xiao Yingqian;Zhao Ya’nan;Xu Cheng(Najing Zeheng Pharma Co.,Ltd.,Najing 210046,China)

机构地区：[1]南京泽恒医药技术开发有限公司,江苏南京210046

出　　处：《广东化工》2020年第20期109-110,154,共3页Guangdong Chemical Industry

摘　　要：目的:建立HPLC法测定巯嘌呤咀嚼片中的有关物质。方法:采用Welch AQ C18(4.6×250 mm,5μm)色谱柱;检测波长:260 nm;流速:1.0 mL/min;流动相:以甲醇-0.1%甲酸(2︰98)为流动相A,以甲醇-0.1%甲酸(50︰50)为流动相B,梯度洗脱。结果:本方法专属性良好;杂质A在0.007~0.724μg/mL范围内线性良好(R=1.0000),杂质B在0.010~0.823μg/mL范围内线性良好(R=1.0000);各杂质的平均回收率在95%~105%,RSD在0.8%~3.4%。结论:本法操作简便,专属性良好,灵敏度和准确度高,可以作为巯嘌呤咀嚼片有关物质的检测方法。Obective:HPLC method was established for the determination of related substances in Mercaptopurine Chewable tablets.Methods:Welch AQ C18(4.6×250 mm,5μm)was used,at the detection wavelength of 260 nm and flow rate of 1 ml/min.The mobile phase A of methanol-0.1%formic acid(2︰98)and the mobile phase B of methanol-0.1%formic acid(50︰50)were used,by gradient elution.Results:The method has good specificity.Impurity A was linear in the range of 0.007~0.724μg/mL(R=1.0000),and impurity B was linear in the range of 0.010~0.823μg/mL(R=1.0000).The recoveries of impurities were 95%~105%,RSDs were between 0.8%~3.4%.Conclusion:The method has good specificity,high sensitivity and accuracy as well as easy to operate.It is a suitable method for the related substances in Mercaptopurine Chewable tablets.

关 键 词：HPLC 巯嘌呤咀嚼片 有关物质 

分 类 号：R927.11[医药卫生—药学]