| 引用本文: | 李煜,张舒,梅梅,杨伟峰,洪利娅.粉末X-射线衍射法测定阿托伐他汀钙片剂中晶型Ⅰ的含量[J].中国现代应用药学,2016,33(10):1293-1296. |
| LI Yu,ZHANG Shu,MEI Mei,YANG Weifeng,HONG Liya.Quantitative Analysis of Crystal Type Ⅰ Content in Atorvastatin Calcium Tablets by Powder X-Ray Diffraction[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(10):1293-1296. |
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| 摘要: |
| 目的 应用粉末X-射线衍射技术对片剂中阿托伐他汀钙的晶型Ⅰ含量进行定量分析。方法 采用缩短扫描范围，降低扫描速度，提高步进扫描时间的精细扫描方法，建立了晶型Ⅰ含量测定的线性方程y=3179.3x-304.56（r=0.992 3），并经方法学验证。结果 对2个规格6个批号片剂的晶型Ⅰ含量进行了测定，结果发现片剂中晶型Ⅰ含量有一定的变化。结论 本法操作简单，在辅料没有干扰的情况下可用于片剂中阿托伐他汀钙晶型Ⅰ含量的定量分析。 |
| 关键词: 阿托伐他汀钙 粉末X-射线衍射 定量测定 晶型含量 |
| DOI：10.13748/j.cnki.issn1007-7693.2016.10.017 |
| 分类号: |
| 基金项目:浙江省食品药品监管系统科技计划项目（2014004） |
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| Quantitative Analysis of Crystal Type Ⅰ Content in Atorvastatin Calcium Tablets by Powder X-Ray Diffraction |
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LI Yu1, ZHANG Shu1, MEI Mei2, YANG Weifeng1, HONG Liya1
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1.Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China;2.College of Chemical Engineering of Zhejiang University of Technology, Hangzhou 310014, China
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| Abstract: |
| OBJECTIVE Quantitative analysis of crystal type Ⅰ content in atorvastatin calcium tablets was established by powder X-ray diffraction. METHODS The linear equation of crystal type Ⅰ content y=3 179.3x-304.56(r=0.992 3) was established by the method of shorting the scan range, decreasing the scan speed and improving the step scan time, the methods was validated by methodology. RESULTS The six batches containing two specifications of crystal typeⅠcontent in atorvastatin calcium tablets were determinated, the results showed that the crystal typeⅠcontent has certain changes. CONCLUSION The method was simple in operation, which can be used in quantitative analysis of crystal type Ⅰ content in atorvastatin calcium tablets under no interference with excipients. |
| Key words: atorvastatin calcium powder X-ray diffraction quantitative determination crystal type content |
