| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 11027364 | Journal of Pharmaceutical and Biomedical Analysis | 2019 | 25 Pages |
Abstract
The separation conditions for Teicoplanin were set on a LiChrospher 100 RP-18 column under gradient elution with a mobile phase composed of ammonium formate 25âmM at pH 6.00 and ACN. The new method was shown equivalent in terms of selectivity to the one reported in the European Pharmacopoeia Teicoplanin monograph, and was validated according to ICH Q2 R1 guidelines for the drug substance assay. The new method offers similar performance to the compendial one but has the advantage of being fully compatible with MS and it can be proposed as a useful tool also for controlling the quality of Teicoplanin fermentation batches and the occurrence of potential impurities.
Keywords
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Giorgio Marrubini, Sara Tengattini, Raffaella Colombo, Davide Bianchi, Fulvio Carlotti, Serena Orlandini, Marco Terreni, Caterina Temporini, Gabriella Massolini,