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Chemometrically assisted development and validation of LC-MS/MS method for the analysis of potential genotoxic impurities in meropenem active pharmaceutical ingredient

Authorized Users Only
2017
Authors
Grigori, Katerina
Loukas, Yannis L.
Malenović, Anđelija
Samara, Vicky
Kalaskani, Anastasia
Dimovasili, Efi
Kalovidouri, Magda
Dotsikas, Yannis
Article (Published version)
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Abstract
A sensitive Liquid Chromatography tandem mass spectrometry (LC MS/MS) method was developed and validated for the quantitative analysis of three potential genotoxic impurities (318BP, M9, S5) in meropenem Active Pharmaceutical Ingredient (API). Due to the requirement for LOD values in ppb range, a high concentration of meropenem API (30 ing/mL) had to be injected. Therefore, efficient determination of meropenem from its impurities became a critical aim of this study, in order to divert meropenem to waste, via a switching valve. After the selection of the important factors affecting analytes' elution, a Box-Behnken design was utilized to set the plan of experiments conducted with UV detector. As responses, the separation factors between the last eluting impurity and meropenem, as well as meropenem retention factor k were used. Grid point search methodology was implemented aiming to obtain the optimal conditions that simultaneously comply to the conflicted criteria. Optimal mobile phase c...onsisted of ACN, methanol and 0.09% HCOOH at a ratio 71/3.5/15.5 v/v. All impurities and internal standard omeprazole were eluted before 7.5 min and at 8.0 min the eluents were directed to waste. The protocol was transferred to LC-MS/MS and validated according to ICH guidelines.

Keywords:
Meropenem / LC-MS/MS / Genotoxk impurities / Box-Behnken / Grid point search methodology
Source:
Journal of Pharmaceutical and Biomedical Analysis, 2017, 145, 307-314
Publisher:
  • Elsevier Science BV, Amsterdam

DOI: 10.1016/j.jpba.2017.06.061

ISSN: 0731-7085

PubMed: 28709127

WoS: 000410872200038

Scopus: 2-s2.0-85022201663
[ Google Scholar ]
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2832
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  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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