Column: Perspectives in Modern HPLC

"Perspectives in Modern HPLC” brings fresh scientific perspectives to chromatography practitioners, covering technical issues, innovative ideas to make chromatography less arduous, and explanations of less-familiar approaches. Columnist Michael W. Dong is a principal at MWD Consulting, where he provides training and consulting services in HPLC, UHPLC, pharmaceutical analysis, and drug quality. He was formerly a senior scientist at Genentech, a research fellow at Purdue Pharma, and senior staff scientist at Applied Biosystems/PerkinElmer.

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Small-Molecule Drug Discovery: Processes, Perspectives, Candidate Selection, and Career Opportunities for Analytical Chemists

August 01, 2022

An overview of modern approaches to small-molecule drug discovery.

The Pharmaceutical Industry and the Separation Scientist: Perspectives, Trends, and Career Opportunities

June 01, 2022

We kick off a new article series that offers an insider’s view of the pharmaceutical industry, focusing on the role of separation science and separation scientists.

New HPLC, MS, and CDS Products Introduced in 2021–2022: A Brief Review

April 01, 2022

Our annual review of new high performance liquid chromatography instruments, mass spectrometry systems, and data processing software.

Column: Perspectives in Modern HPLC

“Practical HPLC Simulator”: A Useful Freeware for Learning HPLC

October 01, 2021

With a new free simulator, educators and students can perform virtual HPLC experiments under isocratic or gradient conditions applicable to real instrumentation and method development.

Bioanalytical Analysis of Small-Molecule Drugs and Metabolites in Physiological Samples by LC–MS, Part 2: Sample Preparation

August 01, 2021

This concise yet comprehensive overview of sample preparation for bioanalysis looks at sample preparation fundamentals, best practices, and modern trends—all illustrated with a case study.

Bioanalysis of Small-Molecule Drugs and Metabolites in Physiological Samples by LC–MS, Part 1: An Overview

June 01, 2021

This is the first article in a four-part series exploring the quantitative assessment of drugs and their metabolites in biological fluids (such as blood, plasma, and urine) and tissue homogenates using liquid chromatography–mass spectrometry (LC–MS).

New HPLC, MS, and CDS Products Introduced in 2020–2021: A Brief Review

April 07, 2021

Highlights of the new high-performance liquid chromatography, mass spectrometry, and chromatography data systems introduced over the past year.

Validation of Stability-Indicating HPLC Methods for Pharmaceuticals: Overview, Methodologies, and Case Studies

November 01, 2020

In the pharmaceutical industry, method validation is essential. But what are the best practices? We review regulatory requirements, validation parameters, methodologies, acceptance criteria, trends, and software tools.

Development of Stability-Indicating Analytical Procedures by HPLC: An Overview and Best Practices

August 01, 2020

Here we provide an overview of the fundamentals and best practices on the development of stability-indicating HPLC methods for drug substances and products. We explain both traditional and easier modern approaches to developing stability-indicating HPLC methods—including using a universal generic method for new chemical entities—and address regulatory considerations and life cycle management strategies.

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Stability Studies and Testing of Pharmaceuticals - An Overview

June 01, 2020

Determining product shelf life is a regulatory requirement for pharmaceuticals and many other regulated consumer products. In this comprehensive overview of stability studies and testing, we summarize current regulatory requirements, share industry practices for forced degradation, and explain approaches for reduced testing and data evaluation to expedite stability study timelines.