Development and validation of an ultra-high performance liquid chromatography coupled to tandem mass spectrometry method for the quantification of the antileishmanial drug paromomycin in human skin tissue

Roseboom, Ignace C.; Thijssen, Bram; Rosing, Hilde; Alves, Fabiana; Younis, Brima M.; Musa, Ahmed; Beijnen, Jos H.; Dorlo, Thomas P. C.

doi:10.1016/j.jchromb.2022.123494

Cited by 2 publications

(1 citation statement)

References 25 publications

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“…Since impurities have no therapeutic effect and may pose safety risks, impurity profiling is essential for drug quality control [22]. Given that PRM and its impurities have similar structures without UV-absorbing chromophores, decent detection techniques should be applied, and few LC-based methods for detecting PRM in human biological matrices have been reported [23][24][25][26]. Hertzler et al [27] developed and validated a volatile reversed-phase HPLC-CAD method that identified nine PRM impurities.…”

Section: Introductionmentioning

confidence: 99%

Highly sensitive liquid chromatographic method combined with online ion suppression to remove interfering anions and mass spectrometry for impurity profiling of paromomycin sulfate

Chen

Zhu

Geng

et al. 2023

J of Separation Science

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A previously developed high-performance liquid chromatography method combined with pulsed amperometric detection allowed to separate many impurities of paromomycin. However, due to the presence of ion pairing agents and sodium hydroxide in the mobile phase, direct coupling to mass spectrometry for the identification of the chemical structures of the impurities was not an option. Indeed, ion suppression was encountered by trifluoroacetic acid and pentafluoroproponic acid in the mobile phase. A cation self-regenerating suppressor, which was originally designed for increasing analyte conductivity of ammonia and amines analysis in ion chromatography, was coupled between the liquid chromatography and ion trap-time of flight-mass spectrometry and almost all trifluoroacetic acid and pentafluoroproponic acid in the mobile phase was removed. The limit of detection of paromomycin in this integrated system improved significantly to 20 ng/ml (0.4 ng). The chemical structures of 19 impurities were elucidated and seven impurities were reported for the first time.

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