Dorina Kotoni

Dorina Kotoni is with Chemical & Analytical Development at Novartis Pharma AG, in Basel, Switzerland.

Articles

Performing chromatographic peak purity assessments (PPA) in the pharmaceutical industry | Image Credit: © Vladimir Polikarpov - stock.adobe.com

Liquid Chromatographic Peak Purity Assessments in Forced Degradation Studies: An Industry Perspective

Pascal Marillier;Neal Adams;Steven W. Baertschi;John M. Campbell;Chris Foti;Juçara Ribeiro Franca;Simon Hicks;Dorina Kotoni;Christian Laue;Stacey Marden;Liping Meng;Ana Claudia de Oliveira Santos;Mariah Ultramari;An Van Cleempoe;Chloe Wang;Todd Zelesky;Zongyun Huang

January 1st 2024

This review article discusses scientific rationales and current best practices in the pharmaceutical industry for performing chromatographic peak purity assessments (PPA). These activities are associated with the development and validation of liquid chromatographic (LC) stability-indicating analytical methods applicable to regulatory submissions of small-molecule drug candidates. The discussion includes a comprehensive overview of the PPA-related regulatory and scientific landscape and common industry approaches to obtain PPA results, as well as the strengths and weaknesses of PDA-facilitated ultraviolet (UV) PPA and other PPA techniques.

The Evolution of Chiral Stationary Phases from HPLC to UHPLC

Dorina Kotoni;Harald Ritchi;Alessia Ciogli;Francesco Gasparrini;Ilaria D’Acquarica;Marco Pierini;Claudio Villani;Jelena Kocergin

March 1st 2014

This article focuses on the progression that chiral stationary phases (CSPs), specifically developed for HPLC, are currently undergoing because of the pressing need of an easy switch to UHPLC.