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Scientific article
English

Development and validation of a heart-cutting liquid chromatography-mass spectrometry method for the determination of process-related substances in cetirizine tablets

Contributors

Rudaz, Serge; Souverain, Sandrine; Schelling, Cédric; Deleers, M.; Klomp, A.; Norris, A.; Vu, T.L.; Ariano, B.; Veuthey, Jean-Luc

Published in

Analytica chimica acta, vol. 492, no. 1-2, p. 271-282

Publication date

2003

Abstract

A heart-cutting liquid chromatography-mass spectrometry (LC-MS) method was developed for the simultaneous analysis of seven process related substances (PRS) at ng ml-1 level in tablets containing cetirizine (CTZ) as active ingredient. After dissolution and filtration, 10 μl of sample was injected onto a cyano-column coupled to an electrospray ionization-mass spectrometer (ESI-MS) equipped with a single quadrupole. A switching valve placed between the analytical column and the MS detector allowed for the transfer of only the PRS fractions into the MS. The separation of PRS and CTZ was achieved in <14 min with a binary gradient using a 50 mM ammonium acetate solution (pH 7) and acetonitrile. The ESI-MS detection was performed using single ion monitoring (SIM). The method was validated. Weighted linear regression was found appropriate in a concentration range of 2.5-250 ng ml-1 and the limit of quantification (LOQ) was estimated at 10 ng ml-1 for each analyte. Method selectivity and robustness was demonstrated. Method performance was evaluated in terms of accuracy and precision using quality control (QC) samples over the investigated range. Finally, the heart-cutting LC-MS method was successfully applied to commercially available tablets.

UNIGE affiliation entities

Citation (ISO format)

RUDAZ, Serge et al. Development and validation of a heart-cutting liquid chromatography-mass spectrometry method for the determination of process-related substances in cetirizine tablets. In: Analytica chimica acta, 2003, vol. 492, n° 1-2, p. 271–282. doi: 10.1016/s0003-2670(03)00339-8

Main files (1)

Article (Published version)

Identifiers

Journal ISSN

0003-2670
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Technical informations

Creation

09/02/2010 09:24:00

First validation

09/02/2010 09:24:00

Update

26/01/2026 12:58:09

Status update

26/01/2026 12:58:09

Last indexation

26/01/2026 12:58:23
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