UPLC-MS/MS in Support of Cleaning Validation Studies

  • Fig. 1: Structures of cephalosporin antibioticsFig. 1: Structures of cephalosporin antibiotics

Pharmaceutical manufacturing equipment has to be cleaned after production in order to avoid cross contamination in the next batch of a different product. The effectiveness of the cleaning process should be confirmed by cleaning validation studies.

An ultra-performance liquid chromatography method with tandem-MS detection (UPLC-MS/MS) was developed for the simultaneous determination of residues of the following beta-lactam ring containing cephalosporin antibiotics on swabs collected from pharmaceutical manufacturing equipment surfaces:

cefuroxime axetil (R) and (S) isomers; cefuroxime, cefixime; cefaclor; cefpodoxime proxetil (R) and (S) isomers; cefalexin, cefadroxil
Any residues that remain on the process equipment after cleaning are removed by using swabs. These residues are extracted from the swabs and the amounts of the compounds are determined without further sample preparation steps by UPLC-MS/MS. Electrospray ionization in negative and positive ion modes have been investigated. The negative electrospray ionization mode [ESI(-)] proved to be more sensitive for cefuroxime and cefuroxime axetil than the positive mode. All other compounds were measured with higher sensitivity using the positive electrospray ionization mode [ESI(+)] For fragmentation of the precursor ions collision induced dissociation (CID) with argon gas was used and detection was performed in the Multiple Reaction Monitoring (MRM) mode.

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Steiner & Co. Deutsche Arzneimittelgesellschaft
Wallenroder Straße 12 - 14
13435 Berlin
Phone: +49 30 710 94 4200
Telefax: +49 30 710 94 4250

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