論文

査読有り 責任著者 国際誌
2019年8月14日

Rapid and efficient high-performance liquid chromatography analysis of N-nitrosodimethylamine impurity in valsartan drug substance and its products.

Scientific reports
  • Sayaka Masada
  • Genichiro Tsuji
  • Ryoko Arai
  • Nahoko Uchiyama
  • Yosuke Demizu
  • Tomoaki Tsutsumi
  • Yasuhiro Abe
  • Hiroshi Akiyama
  • Takashi Hakamatsuka
  • Ken-Ichi Izutsu
  • Yukihiro Goda
  • Haruhiro Okuda
  • 全て表示

9
1
開始ページ
11852
終了ページ
11852
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1038/s41598-019-48344-5

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.

リンク情報
DOI
https://doi.org/10.1038/s41598-019-48344-5
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/31413326
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6694186
ID情報
  • DOI : 10.1038/s41598-019-48344-5
  • PubMed ID : 31413326
  • PubMed Central 記事ID : PMC6694186

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