盐酸文拉法辛多晶型X-射线粉末衍射定量分析

发布时间：2018-10-26 16:56

【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。
[Abstract]:Objective: to determine the content of crystal type 2 in the mixture of crystal type 2 and crystal form 6 of venlafaxine hydrochloride by X ray powder diffraction, and to provide a feasible quantitative analysis method for the quality control of venlafaxine hydrochloride. Methods: the X-ray powder diffraction method was used to characterize the crystal form 2 and crystal form 6 of venlafaxine hydrochloride. The characteristic diffraction peak 2 胃 = 12.62 掳of crystal type 2 and the ratio of peak area of 2 胃 = 11.20 掳of crystal type 6 were selected as quantitative parameters respectively. The standard curve was established to determine the content of crystal type 2 and crystal form 6 in venlafaxine hydrochloride. Results: the ratio of the area of characteristic diffraction peak of crystal type 6 to the area sum of characteristic diffraction peak of crystal type 2 and crystal form 6 in the raw material of venlafaxine hydrochloride showed a good linear relationship with the content of crystal type 6. When the content of crystal type 6 is 5 ~ 95%, the standard curve obtained is as follows: the ratio of peak area to area of the characteristic diffraction peak, the mass fraction of crystal type 6 in the raw material of venlafaxine hydrochloride, and the correlation coefficient (r = 0.999). The precision of the method was 1.86 and the quantitative limit was 5.02. Conclusion: the method is accurate, reliable, rapid and simple, and can be used for quantitative analysis of crystal type 2 and crystal type 6 in venlafaxine hydrochloride.
【作者单位】：上海交通大学药学院;常州四药制药有限公司;
【分类号】：R917

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