SIMPLE PROCEDURE INVOLVING DERIVATIZATION AND THIN-LAYER CHROMATOGRAPHY FOR THE ESTIMATION OF TRACE LEVELS OF HALOGENATED ALKYLAMINES AND THEIR HYDROLYSIS PRODUCTS IN DRUG SUBSTANCES AND FORMULATIONS

Thin-layer chromatographic methods are described for the assessment of residues of aminoalcohols in promethazine, gallamine and mepyramine (pyrilamine) injections using chromogenic/fluorogenic reagents. Detection limits of 8 ppm have been established for 2-dimethylaminopropan-1-ol and 1-dimethylaminopropan-2-ol in promethazine injection, 7 ppm for 2-diethylaminoethanol in gallamine injection and 1 ppm for 2-dimethylaminoethanol in mepyramine injection. These methods enable the assessment of residues of beta-chloroalkylamine alkylating agents. The simplicity and sensitivity of these methods compare favourably with the few literature methods and offer scope for adaptation for other beta-chloroalkylamines in basic drugs.