【摘要】 目的:用X-射线粉末衍射法测定盐酸文拉法辛晶型2和晶型6混合物中晶型2的含量,为盐酸文拉法辛晶型药物的质量控制提供一种切实可行的定量分析方法。方法:采用X-射线粉末衍射法表征盐酸文拉法辛晶型2和晶型6。分别选择晶型2的特征衍射峰2θ=12.62°和晶型6的特征衍射峰2θ=11.20°的峰面积比值为定量参数,建立标准曲线,测定盐酸文拉法辛原料中晶型2和晶型6的含量。结果:盐酸文拉法辛原料中晶型6特征衍射峰峰面积与晶型2和晶型6的特征衍射峰峰面积和的比值,与晶型6的含量呈良好的线性关系;在晶型6含量为5%~95%的范围内,得到的标准曲线为Y=0.010X+0.002。Y为特征衍射峰的峰面积比,X为盐酸文拉法辛原料中晶型6的质量分数,相关系数r=0.999;方法精密度为1.86%;确定定量限为5.02%。结论:所建方法准确可靠,快速简便,可用于盐酸文拉法辛原料中晶型2和晶型6的定量分析。更多还原

【Abstract】 Objective: To develop a method for the quantification of the polymorphic purity of venlafaxine hydrochloridein mixtures of form 2 and form 6 using X-ray power diffraction technique. Methods: In the present study,X-ray powder diffraction method was used to characterize the crystal type 2 and 6 of venlafaxine hydrochloride.A calibration curve was constructed in the range of 5% ~ 95%( w/w) using the characteristic peak ratio of venlafaxine hydrochlorideform 2 at 12. 62° 2θ and form 6 at 11. 20° 2θ as the quantitative parameters to determine the contents of the polymorphs. Results: The quantification method developed was found to be in good linearity in the range of 5% ~ 95%( w/w),and the obtained standard curve was Y = 0. 010 X + 0. 002,where Y was the ratio of characteristic peaks,and X was the mass fraction of venlafaxine hydrochloride form 6. The correlation coefficient was 0. 999,the precision was 1. 86%. and the LOQ was 5. 02%. Conclusion: X-ray powder diffraction method is a feasible analytical method for the quantitative determination of form 2 and form 6 of venlafaxine hydrochloride,which is simple,sensitive and accurate.更多还原