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首页> 美国卫生研究院文献>Scientific Reports >Rapid and efficient high-performance liquid chromatography analysis of N-nitrosodimethylamine impurity in valsartan drug substance and its products
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Rapid and efficient high-performance liquid chromatography analysis of N-nitrosodimethylamine impurity in valsartan drug substance and its products

机译：缬沙坦原料药及其产品中N-亚硝基二甲胺杂质的快速高效液相色谱分析

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摘要

In July 2018, certain valsartan-containing drugs were voluntary recalled in Japan owing to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen. In this study, an HPLC method was developed for the quantitative detection of NDMA simultaneously eluted with valsartan. Good linearity with a correlation coefficient (R2) > 0.999 was achieved over the concentration range of 0.011–7.4 µg/mL. The limits of detection and quantification were 0.0085 μg/mL and 0.0285 μg/mL, respectively. When the recalled valsartan samples were subjected to this method, the observed NDMA contents were in agreement with the reported values, indicating that our method achieved sufficient linearity, accuracy, and precision to detect NDMA in valsartan drug substances and products. Moreover, six samples (valsartan drug substances and tablet formulations), which had a possibility for NDMA contamination, were analyzed; none of the samples contained NDMA at detectable levels. Our method would be useful for the rapid screening and quantification of NDMA impurity in valsartan drug substances and products.
机译：2018年7月，由于受到可能的人类致癌物N-亚硝基二甲胺（NDMA）的污染，日本自愿召回了某些含有缬沙坦的药物。在这项研究中，开发了一种HPLC方法用于定量检测同时用缬沙坦洗脱的NDMA。在0.011-7.4μg/ mL的浓度范围内，线性关系良好，相关系数（R 2 ） 0.999。检测限和定量限分别为0.0085μg/ mL和0.0285μg/ mL。当对召回的缬沙坦样品进行此方法处理时，观察到的NDMA含量与报告值一致，这表明我们的方法具有足够的线性，准确性和精密度，可以检测缬沙坦原料药和产品中的NDMA。此外，分析了六个样品（缬沙坦原料药和片剂），它们可能被NDMA污染。没有一个样品含有可检测水平的NDMA。我们的方法可用于快速筛选和定量缬沙坦原料药和产品中的NDMA杂质。

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