Columns | Column: Perspectives in Modern HPLC

This paper describes the content of a well-written analytical procedure for regulated high-performance liquid chromatography (HPLC) testing. A stability-indicating HPLC assay for a drug product illustrates the required components for regulatory compliance, including additional parameters to expedite a laboratory analyst’s execution.

This article provides a high-level overview of Current Good Manufacturing Practice (cGMP) regulations and related public quality standards.

What you need to know about pharmaceutical regulations as an analytical chemist is provided here, including an explanation about how working in a Good Manufacturing Practice (GMP) environment can yield positive results.

An examination of the new high performance liquid chromatography (HPLC), mass spectrometry (MS), chromatography data systems (CDS), and related products that were introduced over the last year.

This case study of the career path of a separation scientist illustrates the diversified roles of an analytical chemist in nonclinical drug development.

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

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.

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

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.

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.

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).

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

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.

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.

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.

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.

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.

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.

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

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.

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.

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

Comprehensive characterization of ADCs requires increasingly powerful approaches consisting of small- and large-molecule techniques.

An overview and assessment of the latest HPLC and mass spectrometry instruments, modules, chromatography data systems, and related software.

What are the potential problems that may be encountered using UHPLC systems and methods, and what strategies can be used for their mitigation?

UHPLC’s benefits include fast analysis, high-resolution separations, reduced solvent and sample usage, enhanced sensitivity and precision, and more.

In this three-part series, we assess how UHPLC evolved into a modern platform. We start by examining the most important features common to most commercial instruments.

This installment describes HPLC and related products introduced at Pittcon 2017 Chicago and in the year prior. It highlights new HPLC systems, modules, and software, with innovative features and significant benefits to the users.

Quantitative determination of the counterions associated with pharmaceutical salts is a mandatory requirement for quality control. While ion chromatography (IC) is the standard technique in most laboratories, capable of delivering excellent sensitivity, specificity and flexibility, there are other simpler and quicker analytical methodologies that may should be considered for this quality control application.

There can be significant benefits by standardizing HPLC columns in a pharmaceutical development laboratory. Here is a story of how one organization attempted to encourage its staff to develop HPLC methods using fewer column brands and dimensions to reduce waste and efforts in method transfers downstream.

A universal generic HPLC or UHPLC method with a primary modern column that works well for most drug analyses in a few minutes would be an attractive idea for many laboratories. With advances in column technologies, this ideal scenario is becoming more realistic, as demonstrated in the proposed 2-min generic method shown here. In addition, rationales for the selection of column and operating conditions are discussed, together with ways to extend this generic method as a starting point for stability-indicating applications by simple adjustments of gradient time and range.

This installment describes high performance liquid chromatography (HPLC) instruments and related products introduced at Pittcon 2016 held in Atlanta, Georgia, or in the year prior. We highlight innovative features and benefits of new HPLC systems, modules, software, and product extensions.

This fourth and last installment in the series of “Separation Science in Drug Development” provides an overview of modern practices of Quality Control in small molecule drug development including activities such as setting specifications, method validation/transfer, release and stability testing, and authoring CMC sections of regulatory filings.

The third installment in this series provides an overview of modern practices of separation science in small-molecule drug development. It highlights approaches in HPLC method development and physical/chemical characterization to support process chemistry and formulation development, and for assessment/control of the clinical trial materials. The role of the separation scientist in analytical development and salient chromatographic methodology trends are discussed.

This installment provides an overview of high-throughput characterization techniques of drug leads to support small molecule drug discovery programs in a pharmaceutical company. A myriad of analytical chemistry techniques including separation science methodologies are used to confirm the structures and identities, quantitating the concentrations of stock solutions, and measuring key physicochemical properties of the new chemical entities (NCE). A case study is used here to illustrate the details of these applications in high-throughput characterization.

This installment provides an overview of modern practices of high-throughput purification to support small-molecule drug discovery.

This installment highlights noteworthy high performance liquid chromatography (HPLC) and related products introduced at Pittcon 2015 in New Orleans, Louisiana, as well as in the year prior.

The latest approaches to antibody characterization go beyond ion-exchange, size-exclusion, and reversed-phase modes to make use of affinity, hydrophobic interaction, mixed-mode, and HILIC techniques.

Because of improved technologies and other changes in modern HPLC, these seven common practices are now highly questionable.

An updated overview of the development of SPP technology, including benefits, limitations, and the theory behind its success

Noteworthy new HPLC systems and related products

A number of popular myths or half-truths in UHPLC are described and data are provided that contradict some of these commonly held beliefs.

HPLC method development can be accelerated by using three distinct method templates of increasing complexity.

The fundamental concepts of HPLC are re-examined.

A summary of new HPLC systems, modules, and software, focusing on innovations and unique features from a user's perspective.