“Chiral Impurity Methods –Case Study” - HPLC
chiral Impurity Methods case study Ch. LAKSHMI NARAYANADAICEL chiral TECHNOLOGIES (INDIA) PVT LTDIPCIPC--USPUSP8th8thASM 2009ASM 2009 Introduction: chiral Impurity Methods Types of chiral Stationary Phases (CSPs) for HPLCPolysaccharide-CSPs Coated CSPs immobilised CSPs case study : Oxaliplatin chiral HPLC method Lamivudine chiral HPLC method Clopidogrel Bisulphate chiral HPLC methodOverviewOverviewChiral Impurity Methods chiral Impurity Methods IntroductionIntroduction chiral GC chiral HPLC chiral HPCE chiral SFCTypes of CSPs and their loading capacitiesTypes of CSPs and their loading capacitiesDrug discovery today, volume 10, Number 8, April 2005TypeCSPsLoading capacity(mg solute / g CSP)IPirkle type (Brush type)1-50IIPolysaccharide derivatives5 150IIIMacrocyclic Crown Impurity Methods chiral Impurity Methods Types of CSPTypes of CSP1999200120032005Polysaccharide80 5%3%12%87 4%2%7%86 2%1%11%92 4%2% 2%1995-2003 Tetrahedron Asymmetry2005 : J.
Conclusions • Chiral HPLC using polysaccharide derived CSPs is a versatile tool to estimate chiral impurities in drug substances . • Perhaps, the chiral impurity methods described in Pharmacopeia for
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