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MOLNÁR-INSTITUTE sharing streamlined Design Space modelling approaches with HPLC 2023 symposium
Berlin: – The Molnár-Institute for Applied Chromatography will again be a high-profile presence at the 2023 International Symposium on High Performance Liquid Phase Separations (HPLC 23), on its return to Germany.
The Molnár-Institute stand at Booth A2 in the Exhibition Zone at the Düsseldorf CCD Conference Center will present the organization’s revolutionary DryLab®4 separation modelling software that improves the efficiency and success of modern high-performance liquid chromatography (HPLC) through method development, as well as its various leading-edge learning programs.
Molnár-Institute team will be represented by Dr. Imre Molnár (President), Dr. Hans-Jürgen Rieger (Vice President Product Management), Dr. Markus Molnár (Business Strategy) and Mr. Arnold Zöldhegyi (Application Specialist).
Model-based investigation of column selectivities
Molnár-Institute will also contribute to the scientific agenda with a poster presentation from senior scientist Mr. Arnold Zöldhegyi on ‘Finding better column selectivity choices – Using Analytical Design Space Modeling to systematically study and compare selectivities of separation systems across 25 UHPLC-columns’.
The study, co-authored by Mr. Zöldhegyi along with the Institute’s founder and President, Dr. Imre Molnár, and industry subject matter expert Dr. Róbert Kormány, of the Budapest-based Drug Substance Analytical Development Division of Egis Pharmaceuticals Plc., contributes to resolving considerable uncertainty that has arisen within the liquid chromatography community around optimal choice of column hardware and different method development strategies applied (trial-and-error, one-factor-at-the-time and systematic), to find the most appropriate stationary phase or even number of equivalent phases for any given specific separation challenge.
Streamlined Design Space modeling
The research shows how adoption of streamlined modeling approaches for consistent method evaluation and method design, combined with new standards for analytical procedure development, as suggested in recent analytical chapters of International Council for Harmonization (ICH) guidelines Q12, Q14, and Q2(R2) point to building a science-driven, risk-, and knowledge-oriented development routine that ultimately allows transition to a flexible Method Operable Design Region (MODR).
The team used the DryLab® a chromatography-based Design Space modeling software to build a series of 3-D separation models of amlodipine and its related impurities to conduct a comparative test of 25 substantially different UHPLC-columns. Based on requiring no more than twelve input experiments per column, they were able to investigate the impact of all chromatographically relevant method parameters—such as gradient, column temperature, pH of the mobile phase and other instrumental factors—on the efficiency of the separation process. The acquired multivariate eluent design spaces (DS) provided in-depth characterizations of all separation systems while visualizing tolerance ranges within relevant method parameters, as suggested by recent ICH analytical Quality-by-Design (AQbD) guidelines.
Finding shared working areas of stationary phases
The presented study shows that surprising equivalences can exist between substantially different stationary phases and conversely, there were also cases, where albeit the similar column specification, DryLab revealed clear differences between their acquired Design Spaces.
Furthermore, recently introduced advanced multi-attribute modeling options of the software allowed the researchers not only to pinpoint optimum setpoints for each separation system but also to accommodate for further method goals by considering concurrent fulfillments of multiple method-specific criteria such as resolution, runtime, elution window of compounds and peak-shape.
Founded in 1981, Molnár-Institute develops DryLab®4, a software for UHPLC modelling for a world-wide market. Its powerful modules gradient editor, peak tracking, automation, robustness and Design Space Comparison allow for the most sophisticated method development as required across modern pharma industries. Analytical scientists use DryLab®4 to understand chromatographic interactions, to reduce analysis time, to increase robustness, and to conform to Analytical Quality by Design (AQbD) principles, according to the recently published ICH Q14 regulatory framework.
The Molnár-Institute is a registered partner of the US-FDA, CDC and many other regulatory bodies. DryLab®4 pioneered AQbD long before regulatory agencies across the world encouraged such submissions. Widely implemented by thought leaders, the software contributes substantially to the paradigm shift towards a science and risk driven perspective on HPLC Quality Control and Assurance.
Further information at: http://www.molnar-institute.com/
About HPLC Symposium 2023
The International Symposium on High Performance Liquid Phase Separations (HPLC) is an international scientific forum focusing on high-performance liquid chromatography in its various forms, along with complementary separation techniques such as electrophoresis, electrochromatography, field-flow fractionation, supercritical fluid chromatography and hyphenated techniques, such as LC/MS, CE/MS and SFC/MS.
The symposium also considers microfluidic, nanofluidic and chip separations, diagnostic systems, and other leading technologies.
Founded in 1973, the annual symposium alternates between venues in Europe and the USA. Following the previous 2022 conference held in San Diego, California, the 51st HPLC Symposium will return to Germany as a five-day event opening June 18 at the CCD Conference Center, part of the Messe Düsseldorf show grounds.
The 2023 event is organized by the German Chemical Society (GDCh) in partnership with KAD Kongresse & Events KG, with further information at: https://www.hplc2023-duesseldorf.com
Click on Molnár-Institute Method Development Services for other information.