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Micellar electrokinetic capillary chromatography based assay for quantifying residual 4- pyrrolidinopyridine (4-ppy) and 4- dimethylaminopyridine (dmap) in polysaccharide - protein conjugate vaccines
Micellar electrokinetic capillary chromatography based assay for quantifying residual 4- pyrrolidinopyridine (4-ppy) and 4- dimethylaminopyridine (dmap) in polysaccharide - protein conjugate vaccines
The present invention relates to a rapid and reproducible micellar electrokinetic capillary chromatography based method for quantifying residual 4-pyrrolidinopyridine(4- PPY)and4-dimethylaminopyridine(DMAP) in polysaccharide- protein conjugate vaccines prepared by cyanylation conjugation chemistry using 1-Cyano-4- pyrrolidinopyridinium tetrafluorborate (CPPT) and 1 -cyano-4-dimethylaminopyridine tetrafluoroborate (CDAP) respectively.Said method provides separate peaks for residuals(4PPY/DMAP) and polysaccharide-protein conjugate in a given sample,does not require any tedious sample preparation ,is applicable for quantification of 4-PPY and DMAP in any polysaccharide-protein conjugate bulk or vaccine formulation samples and is highly reproducible.Further good precision and linearity of instant method can be attributed to under-pressure mode of injection, injection volume,injection duration, concentration of surfactant and concentration of buffer.
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