The Column - June 2009 - 17

SFC for Pharmaceutical Analysis — Opportunity or Challenge? Melissa Hanna-Brown1 and Tom Lynch,2 1Analytical Research and Development, Pfizer Global R&D Labs, Sandwich, UK. 2Research and Technology Fuels and Lubricants, BP Technology Centre, Whitchurch Hill, Pangbourne, UK. 24 April 2009, Guys Hospital, London, UK. This one day meeting in London was devoted to taking an honest look at supercritical fluid chromatography (SFC) for pharmaceutical analysis. It was attended by approximately 60 people, of which 75% were from industry with the remainder from European academic institutions. The Robens Suite on the 29th floor of Guys Hospital Tower was the ideal venue, which also provided delegates with stunning views across the skyline of London on a clear sunny day. The meeting began with three talks given by Dr Claudio Brunelli (Pfizer Global R&D Labs, Sandwich, UK), Ian Davidson (GSK, Harlow, UK) and Howard Else (Astra Zeneca, Charnwood, UK). These speakers provided an insight into how SFC was being used in their companies. The three perspectives covered a range of different areas, from a research and discovery environment where high throughput/automated chiral and achiral preparative (prep) screening was the focus (GSK), through how Astra Zeneca has developed SFC open access chiral semipreparative support for process R&D, to the work at Pfizer on chiral and achiral separations in late stage development support. Ian Davidson shared his research and discovery experiences of SFC over the last year and covered SFC fundamentals and key instrumental features needed to get the best from his system — these included modified back pressure regulators to improve sensitivity and baselines. He also overviewed the open access screening systems set up to help develop achiral methods efficiently and to support analytical to prep scale-up. Howard Else focused on ‘niche’ chiral separations where SFC has been successfully applied for some time and explained how Astra Zeneca had extended the scope of open access chiral screening systems based around Daicel (coated polysaccharide IA, IB and IC) stationary phases. Else shared the screening decision tree formulated to facilitate screening efficiency, which incorporates both standard typical solvents such as methanol (MeOH), isopropyl alcohol (IPA) and ethanol (EtOH) and atypical solvents such as ethyl acetate (EtOAc), methyl tert-butyl ether (MBTE) and tetrahydrofuran (THF). On late stage project development support, Dr Brunelli described the successes and challenges when using SFC for diverse achiral analytical separations. He focused on both the instrumentation and educational challenges that need to be addressed before SFC can be truly considered a robust and transferable technique. Dr Brunelli outlined his method development strategy starting with stationary phase selection, mobile phase selectivity tuning and then optimization of peak symmetry via ammonium salt-based additives. Other parameters for optimization were also mentioned (i.e., temperature, gradient, flow-rate, pressure) and his summing up pointed out that, as education around the fundamental principles of SFC is low, method development strategy is often an inefficient ‘one factor at a time’ approach. This session was an honest appraisal of the merits of SFC in the armamentarium of analytical tools available to the separation scientist and discussion around the remaining opportunities, with respect to the hardware, was frank and constructive. The second session included five 10-minute vendor snapshots including Thar (Peter Ridgeway), Jasco (Kevin Bayly), Pic Solutions (Mohammed Shaimi), Novasep (Eric Valery) 17 1 9 Contents Tips & Tricks 2 13 Vosloo Rainville and Mather 6 17 News Meeting Review 8 20 Market Trends & Analysis Events & Contacts Lauren Nicole/Getty Images

The Column - June 2009

Table of Contents for the Digital Edition of The Column - June 2009

The Column - June 2009
Laboratory Equipment Qualification: Back to Basics
Market Trends and Analysis
Tips & Tricks: GPC/SEC
Confirming Peak Identification in Bioanalytical Studies Using Dual-Scanning MS Technology to Achieve ProductIon Confirmation
Meeting Review
The Column - June 2009 - The Column - June 2009
The Column - June 2009 - Laboratory Equipment Qualification: Back to Basics
The Column - June 2009 - 3
The Column - June 2009 - 4
The Column - June 2009 - 5
The Column - June 2009 - News
The Column - June 2009 - 7
The Column - June 2009 - Market Trends and Analysis
The Column - June 2009 - Tips & Tricks: GPC/SEC
The Column - June 2009 - 10
The Column - June 2009 - 11
The Column - June 2009 - 12
The Column - June 2009 - Confirming Peak Identification in Bioanalytical Studies Using Dual-Scanning MS Technology to Achieve ProductIon Confirmation
The Column - June 2009 - 14
The Column - June 2009 - 15
The Column - June 2009 - 16
The Column - June 2009 - Meeting Review
The Column - June 2009 - 18
The Column - June 2009 - 19
The Column - June 2009 - Events
The Column - June 2009 - 21