LCGC Asia Pacific-03-01-2017

Separation scientists may seek an optimum spot between chromatographic performance required to obtain sufficient results quality, and the time and resources needed to do so. This instalment of “GC Connections” examines the factors that control peak resolution-one of the main drivers of separation quality-and how chromatographers can use this information to find an optimum between time, cost, and performance.

Chromatographic techniques with mass spectrometric detection are important enablers in modern drug discovery. With the development of robust instrumentation and implementation of user-friendly software (or software packages), non-expert users can now walk up to easily accessible advanced chromatographic systems and perform experiments at their own convenience. Although remarkable improvements in robustness and ease-of-use have happened since the introduction of the first high performance liquid chromatography–mass spectrometry (HPLC–MS) systems, the instrument performance still needs to be qualified and monitored to ensure consistent high-quality results. This article will demonstrate how a simple test mixture of carefully selected compounds can facilitate both the development of generic ultrahigh-pressure liquid chromatography–mass spectrometry (UHPLC–MS) methods and automated performance monitoring of multiple instruments located in separate laboratories and buildings.

Interest in chromatography using hydrophilic interaction liquid chromatography (HILIC) has continued to build in recent years. Adoption of the technique has been slowed by experiences of poor reproducibility. In particular, reequilibration times in HILIC have been reported as being exceptionally long as compared to reversed-phase chromatography. In this study, reequilibration times in HILIC for both aqueous–organic gradients and buffer gradients are systematically explored. The results not only promise to improve method development practices, but also provide insight into HILIC retention mechanisms across mechanistically differing polar stationary phases.

All agencies have issued varying guidances for the approval of recombinant biosimilars of biopharmaceuticals, and all submittals are considered on a case-by-case basis. This instalment of “Focus on Biopharmaceutical Analysis” looks at the best methodologies for demonstrating their analytical comparability.

Click the title above to open the LCGC Asia Pacific March 2017 regular issue, Vol 20, No 1, in an interactive PDF format.