| 厄贝沙坦多晶型X-射线粉末衍射定量分析 |
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| 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. DOI: 10.13748/j.cnki.issn1007-7693.2021.12.014 |
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| 作者姓名： | 楼永军 左丽丽 |
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| 作者单位： | 浙江省食品药品检验研究院, 国家药品监督管理局仿制药评价关键技术重点实验室, 杭州 310052;浙江工业大学, 杭州 310014 |
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| 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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| 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％～5...
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| 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 |
| 收稿时间： | 2020-04-07 |
Quantitative Determination of Irbesartan Polymorphs by X-ray Powder Diffraction |
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| LOU Yongjun, ZUO Lili. Quantitative Determination of Irbesartan Polymorphs by X-ray Powder Diffraction[J]. Chinese Journal of Modern Applied Pharmacy, 2021, 38(12): 1490-1492. DOI: 10.13748/j.cnki.issn1007-7693.2021.12.014 |
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| Authors: | LOU Yongjun ZUO Lili |
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| Affiliation: | Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Hangzhou 310052, China;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. |
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| Keywords: | irbesartan|form A|form B|X-ray powder diffraction|standard curve|quantitative determination |
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