Authors: N V V S S Raman A V S S Prasad K Ratnakar Reddy K Ramakrishna
Publish Date: 2017/02/09
Volume: 80, Issue: 3, Pages: 447-452
Abstract
Sensitive methods for the determination of three potentially genotoxic impurities PGIs namely 1bromo3chloropropane BCP 14nitrobenzyl1H124triazole NBT and 1bromomethyl4nitrobenzene BNB in rizatriptan benzoate RTB have been developed using hyphenated techniques BCP was determined by GC–MS while NBT and BNB were determined by LC–MS These techniques have been selected based on the structural alerts SAs sensitivity and stability of PGI under study All the developed methods were validated as per International Council for Harmonization ICH guidelines The quantitation limit was found to be 150 ppm and the linearity ranged from 150 to 750 ppm for all the three methods The correlation coefficient values were found to be 0999 indicating the best fitness of the calibration curves The recoveries ranged from 80 to 120 signifying the good accuracy of the developed methods
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