Quantitative Detection for Polymorph of Levonorgestrel by Powder X-ray Diffraction
10.3870/j.issn.1004-0781.2019.02.011
- VernacularTitle:粉末X射线衍射技术定量分析左炔诺孕酮晶型
- Author:
Cheng XING
1
;
Junzi CAO
;
Li ZHANG
;
Ningbo GONG
;
Shiying YANG
;
Guanhua DU
;
Yang LYU
Author Information
1. 中国医学科学院北京协和医学院药物研究所晶型药物研究北京市重点实验室
- Keywords:
Levonorgestrel;
Polymorphs;
Powder X-ray diffraction;
Quantitative analysis
- From:
Herald of Medicine
2019;38(2):193-197
- CountryChina
- Language:Chinese
-
Abstract:
Objective According to the clinical medicinal crystal form———form γ of levonorgestrel, to establish the quantitative analysis method for levonorgestrel form γ by powder X-ray diffraction (PXRD) . Methods Firstly, single crystal X-ray diffractometry and powder X-ray diffractometry were used to confirm that the prepared levonorgestrel form γ was 100％ polymorphic purity, which provided a standard sample for quantitative analysis by single peak method; then, the standard samples of different quality levonorgestrel form γ for powder X-ray diffraction were weighed, the peak intensity values of characteristic diffraction peaks d = 6.4 , d = 6. 1 and d = 5. 6 of form γ as quantitative parameters selected, a linear relationship between the peak intensity value and the quality of form γ was established; finally, the content of levonorgestrel form γ was quantitatively analyzed. Results The peak intensity values of characteristic diffraction peaks d = 6.4 , d = 6.1 and d = 5.6 of levonorgestrel form γ and the quality showed a good linear relationship.In the range of form γ masses of 5 mg to 50 mg, the regression linear equations wereY = 459.59X+5 536.5, R2 = 0.993 0, Y = 430.03X+6 867.6, R2 = 0.990 5,Y = 615.95X+ 6 209.5, R2 = 0.990 8,respectively. Conclusion The method is simple, rapid, accurate and reliable, it can be used as quality control method for levonorgestrel polymorphs.
