Journal of Pharmaceutics & Drug Delivery ResearchISSN: 2325-9604

All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

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
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

international publisher, scitechnol, subscription journals, subscription, international, publisher, science

Track Your Manuscript

Awards Nomination

open access