About the Topic

Course description

HPLC method development is an arduous and time-consuming process generally reserved for experienced separation scientists. This 1/2-day intermediate-level training workshop provides a critical overview of best practices, short cuts and tricks-of-the-trade to help the pharmaceutical scientist to become more successful in rapid development of effective (u)HPLC methods (potency and ICH-compliant stability-indicating assays) using a 3-pronged method template approach, a universal generic gradient methodology for multiple NCEs, and an effective Quality by Design (QbD) software platform using an automated approach.

Who Should Attend

This workshop is intended for analysts, managers, and researchers using HPLC in the pharmaceutical laboratory wishing to learn how to develop HPLC or UHPLC methods quickly and more effectively. A fundamental understanding of HPLC is assumed and some practical hands-on HPLC method development experience is highly recommended.

Workshop Agenda

A. The Traditional Method Development Approach  

1. Glossary, Insights, Steps in traditional method development, Scouting gradient and getting the first chromatogram, method fine-tuning and optimization (Solvent strength/type, pH, buffer/additive, F, T, tG), Case studies for method development of a phase 0 method for a new chemical entity (NCE).
2. General method development strategy, forced degradation studies to demonstrate method specificity, method development trends, Phase-appropriate method development, development of secondary “orthogonal” methods, automation screening systems and software tools, Fusion QbD.

B. The 3-Pronged Template Approach for Rapid Method

1.  Fast LC isocratic methods for potency or performance assessment, generic broad-gradient methods for in-process control, high-throughput screening, purity assays of starting materials and cleaning verification Multi-segment gradient methods for ICH compliant stability-indicating assays of complex molecules, case studies of multichiral drugs and complex products with multiple APIs, references

C. Modern Universal Generic Gradient Method(s):

1. Introduction of a universal generic gradient method(s), This fast LC method is capable of peak capacities of 100-300 in 2 to 5 minutes, Rationales of selection of column and operating conditions (CSH, SPP, tG), method adjustments, Case studies for cleaning verification of multiple NCEs, purity assays including compounds with multiple chiral centers.

D. Quality by Design (QbD) Approach to method development:

1. Introduction to QbD, Design of Experiments (DoE), and ICH Q8(R2), QbD approach to method development using S-Matrix Fusion QbD software platform, case studies illustrating workflows and results.

Learning Outcomes

The pharmaceutical scientist will learn the traditional HPLC method development strategy supplemented by a quicker 3-pronged template approach for rapid method development, the use of a universal generic gradient method(s) for multiple new chemical entities and a QbD approach to method development using S-Matrix Fusion QbD software for automated system control and statistical data analysis.