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核磁共振波谱法测定药物基准物质的绝对含量
引用本文:胡敏,胡昌勤,刘文英.核磁共振波谱法测定药物基准物质的绝对含量[J].分析化学,2004,32(4):451-455.
作者姓名:胡敏  胡昌勤  刘文英
作者单位:1. 湖北药品检验所,武汉,430064
2. 中国药品生物制品检定所,北京,100050
3. 中国药科大学药物分析教研室,南京,210009
摘    要:探讨在新药基准物质的确定过程中,利用核磁共振法测定药物绝对含量的可行性。以环丙沙星、安妥沙星、卡德沙星、加替沙星、左氧氟沙星、氧氟沙星、诺氟沙星、依诺沙星和洛美沙星9种喹诺酮类抗生素化学对照品为例,其中安妥沙星和卡德沙星为国家一类新药。采用重水、氘代二甲基亚砜或氢氧化钠的重水溶液为溶剂,对苯二酚或顺丁烯二酸为内标,用喹诺酮母核上的质子峰进行定量,以内标法和外标法计算含量。核磁共振法测定结果与各对照品标签示值的误差约为1%,内标法和外标法的计算结果一致。该方法专属、准确、简便、快速,适用于对药物基准物质绝对含量的测定。

关 键 词:药物基准物质  绝对含量  含量测定  核磁共振波谱法  新药研制开发  喹诺酮类抗生素

Determination of Drug Reference Substance Content by 1 H-Nuclear Magnetic Resonance (NMR) Spectroscopy
Hu Min.Determination of Drug Reference Substance Content by 1 H-Nuclear Magnetic Resonance (NMR) Spectroscopy[J].Chinese Journal of Analytical Chemistry,2004,32(4):451-455.
Authors:Hu Min
Abstract:This article discussed the feasibility of determining the content of reference substance by 1H nuclear magnetic resonance spectroscopy (NMR). 9 reference substances of quinolone antibiotics were chosen as examples, such as ciprofloxacin, antofloxacin, caderofloxacin, gatifloxacin, L ofloxacin, ofloxacin, norfloxacin, enoxacin, lomefloxacin. D 2O, D 6 dimethyl sulfoxide (DMSO), or 0.3 mol/L NaOH in D 2O solution was used as solvent. Hydroquinone and maleic acid were selected as internal standard. By measuring the selected proton peak intensity, the quantitative analysis of samples was achieved. The difference between the result of NMR method and labelled content was about 1%. The results came from the internal standard method were same as those of external standard one. This method is specificity, rapid, accurate, simple, and it is suitable for the quantitative determination of the reference substance content.
Keywords:Nuclear magnetic resonance  quantitative analysis    quinolone  
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