"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.

Column: Perspectives in Modern HPLC

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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. 

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

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.

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

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.

Stability Studies and Testing of Pharmaceuticals: An Overview

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.

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

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.

Chromatography Data Systems: Perspectives, Principles, and Trends

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.

Ultraviolet Detectors: Perspectives, Principles, and Practices

We explain recent trends in HPLC autosampler design, provide recommendations for selecting one, and offer guidelines for operation and troubleshooting.

HPLC Autosamplers: Perspectives, Principles, and Practices

New HPLC and MS systems: A review of instrumentation trends and the current market along with new instruments, modules, chromatography data systems, and related software.

New HPLC Systems and Related Products Introduced in 2018–2019: A Brief Review

Modern trends in LC mobile-phase selection and preparation include using simpler mobile phases, increased use of MS-compatible mobile phases, and eliminating filtration and certain mobile-phase additives. Here, we discuss those and other trends and best practices, as well as the fundamentals behind them.

Modern Trends and Best Practices in Mobile-Phase Selection in Reversed-Phase Chromatography

These ten propositions are widely acknowledged, but frequently neglected, by practitioners of high performance liquid chromatography (HPLC).