Применение метода ВЭЖХ-МС/МС высокого разрешения для идентификации и количественного определения примесей в субстанции препарата «Ломустин»

Irina O.  Reshetnikova; Sergey V.  Metlitsckih; Nadezhda D.  Stekleneva; Alexander N.  Volov

doi:10.25514/CHS.2021.1.19009

Irina O. Reshetnikova D.I. Mendeleev Central Research Institute of Chemistry and Mechanic, Moscow, Russia https://orcid.org/0000-0003-1779-169X
Sergey V. Metlitsckih D.I. Mendeleev Central Research Institute of Chemistry and Mechanic, Moscow, Russia; I.M. Sechenov First Moscow State Medical University, Moscow, Russia https://orcid.org/0000-0001-9312-8297
Nadezhda D. Stekleneva D.I. Mendeleev Central Research Institute of Chemistry and Mechanic, Moscow, Russia https://orcid.org/0000-0002-9866-8521
Alexander N. Volov D.I. Mendeleev Central Research Institute of Chemistry and Mechanic, Moscow, Russia https://orcid.org/0000-0002-6389-6372

DOI: https://doi.org/10.25514/CHS.2021.1.19009

Keywords: lomustine, 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea, specific impurities, 1,3-bis(2-chloroethyl)urea, 1-(2-chloroethyl)-3-cyclohexylurea, 1,3-dicyclohexylurea, HPLC-MS/MS tandem mass-spectrometry.

Abstract

A highly efficient liquid chromatography–quadrupole-time of flight mass spectrometry (HPLC-QTOF-MS) method was proposed for the study of solutions of the substance standards of the drug Lomustin, which is included in the List of Vital Drugs, as well as specific impurities regulated by the European Pharmacopoeia. As a result of the study, a new specific impurity was found.

References

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European pharmacopoeia 7.0. 07/2010: 0928 Lomustine.

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Snyder L.R., Kirkland J., Dolan J. W. (2020) Introduction To Modern Liquid Chromatography. М.: Technosfera (in Russ.).

Application of the HPLC-QTOF method for the identification and quantitative determination of impurities in the substance of the drug «Lomustine»

Abstract

References

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