Dear Colleagues,

Compendial and other official chromatographic methods often give the impression of being awkward and/or old-fashioned. This is mainly because chromatography base materials, and the chemical modifications thereof as well as the instruments, have been continuously improved over the years, but where the methods have not kept up with speed and performance. In pharmaceutical analysis, this subject is of particular relevance. It is a general feeling that there is the need to modernize many of the existing monographs both in terms of the materials that can be used and to find alternative separation mode solutions. HPLC columns of traditional format (250x4.6 mm, packed with particles of 10 or 5 microns diameter) are obsolete and could be successfully replaced by greener and more efficient columns having smaller formats. Also, modern materials for stationary phases do not suffer any more of the problems of the past, such as metals contamination and free silanols secondary interactions. Therefore, a change in the composition of the mobile phase may also be necessary when it comes to the time to change the old column used for a compendial method.

Ion-chromatography and Hydrophilic Interaction Liquid Chromatography (HILIC) have been shown as valuable complements to reversed-phase LC and are today viable and robust options together with normal-phase LC.

As strong evidence of this trend, the United States Pharmacopoeia (USP), for about ten years, started a global initiative to modernize existing monographs actively seeking industry collaborators to assist in the development of new monographs. Also, the scientific community is expecting soon the release of the final document of ICH Q14 “Analytical Procedure Development and Revision of Q2(R1) Analytical Validation” guideline that should list new requirements for validation of measurement methods.

This Special Issue aims to present readers with the latest research regarding method scaling, alternative separation mode solutions, and innovative approaches to tackle pharmaceutical analysis. The issue invites contributions relating, but not limited to, innovation in chromatographic pharmaceutical analysis, method development, and multivariate tools for data treatment.

Dr. Giorgio Marrubini
Guest Editor

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• phamaceutical analysis
• USP alternative methods
• method scaling
• method adaptations
• ion chromatography
• HILIC
• multivariate approaches
• design of Experiments
• quality by Design
• changes in compendial methods