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.

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.

LCGC North America

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.

LCGC North America

New HPLC Systems and Related Products Introduced in 2019–2020: A Brief Review

April 01, 2020

Our annual review of new high performance liquid chromatography and mass spectrometry instruments, chromatography data systems (CDS), and related products, including a summary of their significant features and user benefits.

LCGC North America

Chromatography Data Systems: Perspectives, Principles, and Trends

December 01, 2019

This technical overview of chromatography data systems (CDS) looks at how CDS are designed, how they can be used most effectively, and what developments we can expect in the future.

LCGC North America

Ultraviolet Detectors: Perspectives, Principles, and Practices

October 01, 2019

The authors provide a technical overview of the design and operating principles of variable wavelength and photodiode array detectors, and include historical perspectives and common practices in operation and maintenance.