Journal of Pharmaceutics & Drug Delivery Research ISSN: 2325-9604

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: [email protected]
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.

Keywords: Liquid chromatography mass spectrometry; Rizatriptan benzoate; Genotoxic impurities; 1-(4-Nitrobenzyl)-1,2,4-triazol, 4-(1H-1,2,4- Triazol1-yl methyl) benzene amine; 4-Amino-1-(4-nitrobenzyl)- 1,2,4-triazolium bromide

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