Liquid Chromatography (LC/HPLC)

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

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.

Tubes | Image Credit: © Sirer - stock.adobe.com

The gradient delay volume is arguably one of the most important, yet least appreciated, parameters that affect how gradient elution separations in LC work. This has implications both for method development and for method transfer during the lifecycle of a LC method. In this installment, I will review the concept of gradient delay volume, its physical connection to the LC instrument, and how it can impact method development and separation quality.

Ultra high performance chromatography (HPLC) setup for separation and analytical chemistry. | Image Credit: © Artur Wnorowski - stock.adobe.com

This paper proposes a new method of flash qualitative identification (FQI) to qualitatively identify a certain target component from a mixture within half a second by disusing the analytical column, which is a time-consuming unit in current chromatography instruments. First, a Noised Spectrum Identification (NSI) model was constructed for the data set generated directly by diode array detector (DAD) without the process in an analytical column. Then, a method called vector error algorithm (VEA) was proposed to generate an error according to the DAD data set for a mixture and a specific spectrum for the target component to be identified. A criterion based on the error generated by the VEA is used to give a judgement of whether the specific spectrum exists in the DAD data set. Several simulations demonstrate the high performance of the FQI method, and an experiment for three known materials was carried out to validate the effectiveness of this method. The results show that the NSI model concurs with the real experiment result; therefore, the error generated by the VEA was an effective criterion to identify a specific component qualitatively, and the FQI method could finish the identification task within half a second.

This month we spoke to Zhuoheng Zhou from the Vrije Universiteit Brussel in Belgium about his research on advancing instrumental and column technologies for modern chromatography and its applications in novel biopharmaceutical modalities and proteomics.

Town Hall in center of Leuven at sunset, Belgium | Image Credit: © Mistervlad - stock.adobe.com

HTC-18 Preview

The 18th International Symposium on Hyphenated Techniques in Chromatography and Separation Technology (HTC-18) will be held from 28–31 May 2024 in Leuven, Belgium.

Intense cluttering of blood cells | Image Credit: © Argus - stock.adobe.com

Scientists from South Dakota State University and the University of Colorado School of Medicine created a system to detect traces of cyanide in blood samples using liquid chromatography–tandem mass spectrometry (LC–MS/MS).