高效液相色谱法测定进出口医疗器械中的MDI溶出量  

Determination of MDI Dissolution in Import and Export Medical Devices by HPLC

作　　者：王燕 傅科杰 华正江 冯云 冯睿 WANG Yan;FU Ke-Jie;HUA Zheng-Jiang;FENG Yun;FENG Rui(Technical Center of Ningbo Customs District,Ningbo 315012)

机构地区：[1]宁波海关技术中心,宁波315012

出　　处：《中国口岸科学技术》2022年第11期40-46,共7页China Port Science and Technology

摘　　要：建立了液相色谱法测定进出口医疗器械中二苯甲烷二异氰酸酯(diphenylmethane diisocyanate,MDI)溶出量的方法。本方法以甲醇作为提取溶剂和衍生化试剂,将MDI衍生为二苯甲烷二氨基甲酸甲酯(methylene diphenyl dicarbamate,MDC),通过高效液相色谱法(high performance liquid chromatography,HPLC)测定MDC的量从而推出MDI溶出量。结果表明本方法在0.5~100μg/mL范围内线性关系良好,相关系数为0.9999,平均加标回收率为83.5%~98.7%,日内精密度和日间精密度分别为0.10%(n=6)和0.91%(n=3),说明本方法具有较高的准确度和精密度,能够满足进出口医疗器械中MDI溶出量的测定需求。A liquid chromatography method for the determination of diphenylmethane diisocyanate(MDI)in import and export medical devices by liquid chromatography was established.In this method,methanol was used as the extraction solvent and derivatization reagent,and MDI was derived into methylene diphenyl dicarbamate(MDC).The amount of MDC was determined by high performance liquid chromatography(HPLC)to deduce the amount of MDI dissolved.The calibration curve was linear over the concentration range of 0.5-100μg/m L,and the correlation coefficient was 0.9999.The average recoveries of standard addition ranged from 83.5%to 98.7%,the RSDs of intra and inter day were 0.10%(n=6)and 0.91%(n=3),respectively.This method had a high accuracy with satisfactory results,which can be used for the determination of MDI dissolution in import and export medical devices.

关 键 词：二苯甲烷二异氰酸酯(MDI) 二苯甲烷二氨基甲酸甲酯(MDC) 溶出量 进出口医疗器械 

分 类 号：TH77[机械工程—仪器科学与技术] O657.72[机械工程—精密仪器及机械]