| 引用本文: | 楼永军,左丽丽.厄贝沙坦多晶型X-射线粉末衍射定量分析[J].中国现代应用药学,2021,38(12):1490-1492. |
| LOU Yongjun,ZUO Lili.Quantitative Determination of Irbesartan Polymorphs by X-ray Powder Diffraction[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(12):1490-1492. |
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| 摘要: |
| 目的 建立厄贝沙坦晶型原料药的晶型含量分析方法，为药品晶型质量控制提供技术支撑。方法 采用X-射线粉末衍射法表征厄贝沙坦晶型A和晶型B。分别选取晶型A的特征衍射峰2θ=4.65°和晶型B的特征衍射峰2θ=7.99°的峰面积比值为定量参数，建立标准曲线检测晶型B的含量。结果 晶型B在晶型A和晶型B混合物中含量为2%~50%（质量分数）内线性关系良好（r=0.999 5），方法仪器精密度为4.7%，检测限浓度为1.12%（S/N=4.4）。结论 本研究建立的方法准确方便，可用于厄贝沙坦原料晶型A和晶型B混合物中晶型B的定量分析。 |
| 关键词: 厄贝沙坦|晶型A|晶型B|X-射线粉末衍射|标准曲线|定量分析 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.12.014 |
| 分类号:R917 |
| 基金项目:“重大新药创制”国家科技重大专项（2017ZX09101001）；浙江省食品药品检验研究院重点项目[浙食药检（2013）38号] |
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| Quantitative Determination of Irbesartan Polymorphs by X-ray Powder Diffraction |
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LOU Yongjun1,2, ZUO Lili2
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1.Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Hangzhou 310052, China;2.Zhejiang University of Technology, Hangzhou 310014, China
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| Abstract: |
| OBJECTIVE To establish a method for the determination of the contents of irbesartan polymorphs and to provide technical support for the quality control of crystal forms. METHODS X-ray powder diffraction method was used to characterize form A and B of irbesartan. A standard curve method was developed by using the characteristic peak ratio of form A at 4.65° 2θ and form B at 7.99° 2θ as the quantitative parameters, and the content of form B was calculated by the standard curve. RESULTS The curve of form B in the mixtures of form A and B was linear over the range of 2%-50% with r of 0.999 5, the instrument precision was 4.7%, and the concentration of LOD was 1.12%(S/N=4.4). CONCLUSION The established method is accurate, simple, and can be used to determine the contents of form B in the mixtures of form A and B. |
| Key words: irbesartan|form A|form B|X-ray powder diffraction|standard curve|quantitative determination |
