Columns | Column: Perspectives in Modern HPLC

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.