| 陈煜,蒋林惠.L-5-甲基四氢叶酸钙液相分析方法验证[J].食品安全质量检测学报,2019,10(4):1060-1063 |
| L-5-甲基四氢叶酸钙液相分析方法验证 |
| Application of HPLC mathematical statistics in Calcium L-5-Methyltetrahydrofolate |
| 投稿时间：2018-12-14 修订日期：2019-01-17 |
| DOI： |
| 中文关键词: L-5-甲基四氢叶酸，液相色谱法，分析方法验证 |
| 英文关键词:Calcium L-5-Methyltetrahydrofolate,Liquid chromatography,Analysis method validation |
| 基金项目:南通市市级科技计划（YYZ 17098） |
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| 中文摘要: |
| 依据2015版中华人民共和国药典第四部通则中《9101药品质量标准分析方法验证指导原则》的要求，对L-5-甲基四氢叶酸钙液相分析方法进行了验证,结论：检出限为0.015μg/mL，定量限为0.05，μg/mL，RSD为0.31%，加标回收率范围97.3%-114%，方法适用。 |
| 英文摘要: |
| the method of liquid phase analysis of L-5-methyltetrahydrofolate was verified according to the requirements of the "Guidelines for Validation of the Standard Analysis Method for Drug Quality 9101" in the fourth edition of the 2015 edition of the Pharmacopoeia of the People's Republic of China. Result: The detection limit was 0.015μg/mL, the quantitative limit was 0.015μg/mL, the RSD was 0.31%,the recoveries was in the range of 97.3-114%. |
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