粉末X-射线衍射技术定量测定注射用美罗培南中美罗培南晶型I的含量

Quantitative determination of crystal type I in meropenem for injection by powder X-ray diffraction

目的采用粉末X-射线衍射技术(powder X-ray diffraction,PXRD)对三家公司的注射用美罗培南制剂中美罗培南晶型I进行定量分析和对比。方法采用粉末X-射线衍射精细扫描方法,选择2θ=12.9°特征衍射峰强度经被试验样品质量校正后作为定量参数,建立标准曲线,测定三家公司的注射用美罗培南中美罗培南晶型I的含量,并与高效液相方法测定制剂中美罗培南的总含量进行比较。结果在美罗培南晶型I含量为5%~120%的范围内,得到的标准曲线为Y=553.8X-105.9(r=0.9984);三家公司制剂中晶型I含量均略低于美罗培南总含量。结论建立方法操作简单快捷,能够在辅料没有干扰的情况下用于注射用美罗培南中美罗培南晶型I的含量分析,可为美罗培南的质量控制和晶型稳定性研究提供参考。

Objective To quantitatively analyze and compare the crystal type I in meropenem for injection from three companies by powder X-ray diffraction(PXRD).Methods Using fine scanning method,a calibration curve was established by correcting the characteristic peak intensity at 2θ=12.9°with the mass of mixed sample as the quantitative parameter.The content of crystal type I was determined from three companies and compared with total content in HPLC method.Results When the content of meropenem crystal type I was 5%~120%,the calibration curve was Y=553.8 X-105.9(r=0.9984).The content of crystal type I in the preparations from three companies was slightly lower than the total content of meropenem.Conclusion The method established in this paper is simple and fast,and can be used for the content analysis of meropenem crystal type I without interference of excipients.It can provide a reference for the quality control and crystal type stability of meropenem for injection.