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Hindi Research Article, J Pharm Drug Deliv Res Vol: 6 Issue: 1
Simultaneous Quantitation of Three Genotoxic Impurities in Rizatriptan Benzoate Using Liquid Chromatography-Mass Spectrometry
| Niranjan MD*, Manish GG, Yogesh JC, Nelson R D’souza, Navin VD and Jaydeep NG | |
| Cipla Limited, L.B.S. Marg, Vikhroli (W), Mumbai-400 083, India | |
| Corresponding author : Niranjan M Deshpande Cipla Limited, L.B.S. Marg, Vikhroli (W), Mumbai-400083, India Tel: +91 9819930539, +91 22-2575 6088 E-mail: niranjan.deshpande@cipla.com |
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| Received: March 06, 2017 Accepted: March 31, 2017 Published: April 02, 2017 | |
| Citation: Niranjan MD, Manish GG, Yogesh JC, D’souza NR, Navin VD, et al. (2017) Simultaneous Quantitation of Three Genotoxic Impurities in Rizatriptan Benzoate Using Liquid Chromatography-Mass Spectrometry. J Pharm Drug Deliv Res 6:1. doi: 10.4172/2325-9604.1000163 |
Abstract
A selective, sensitive and high throughput Liquid Chromatography Mass Spectrometry method has been developed for simultaneous quantification of three genotoxic impurities in Rizatriptan Benzoate. Three genotoxic impurities of Rizatriptan Benzoate namely 1-(4-Nitrobenzyl)-1,2,4-triazol, 4-(1H-1,2,4-Triazol1-yl methyl) benzene amine and 4-Amino-1-(4-nitrobenzyl)-1,2,4-triazolium bromide were separated on Zorbax SB-CN (150 mm × 4.6 mm, 3.5 µm) column using 10 mM ammonium acetate as buffer and acetonitrile as organic modifier in gradient composition at the flow rate of 1.0 ml/ min. All the impurities exhibited linearity with correlation of coefficient value greater than 0.990. The method was validated over the concentration range of 5 µg/g-70 µg/g for all the three impurities according to ICH guidelines. The method was successfully applied for the determination of three genotoxic impurities in Rizatriptan Benzoate drug substances.
