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Determination of 1-Bromo-3-Chloropropane, 1-(4-Nitrobenzyl)-1H-1,2,4-Triazole, and 1-(Bromomethyl)-4-Nitrobenzene in Rizatriptan Benzoate
- Raman, N. V. V. S. S., Prasad, A. V. S. S., Reddy, K. Ratnakar, Ramakrishna, K.
- Chromatographia 2017 v.80 no.3 pp. 447-452
- correlation, gas chromatography-mass spectrometry, guidelines, liquid chromatography, mutagens
- Sensitive methods for the determination of three potentially genotoxic impurities (PGIs), namely 1-bromo-3-chloropropane (BCP), 1-(4-nitrobenzyl)-1H-1,2,4-triazole (NBT), and 1-(bromomethyl)-4-nitrobenzene (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 15.0 ppm and the linearity ranged from 15.0 to 75.0 ppm for all the three methods. The correlation coefficient values were found to be 0.999 indicating the best fitness of the calibration curves. The recoveries ranged from 80 to 120% signifying the good accuracy of the developed methods.