Asian Journal of Research in Chemistry
  • Year: 2018
  • Volume: 11
  • Issue: 5

Method Development and Validation of RP-UPLC method for the determination of Dabigatran Etexilate Mesylate in API

  • Author:
  • B. V. Narasimha Raju Katari1,2,, V.V.S.R.N. Anji Karun Mutha1,2, Muralidharan Kaliyaperumal1, Chidananda Swamy Rumalla1, Ragu Babu Korupolu2, Annapurna Nowduri2
  • Total Page Count: 4
  • Page Number: 787 to 790

1Department of Medicinal Chemistry, GVK Biosciences Pvt. Ltd, IDA Mallapur, Hyderabad, Telangana, India-500076

2Department of Engineering Chemistry, Andhra University, Visakhapatnam, Andhra Pradesh, India-530003

*Corresponding Author E-mail: kbvn4u@gmail.com

Online published on 20 December, 2018.

Abstract

The UPLC method was developed and validated for the determination of Dabigatran Etexilate Mesylate (DEM). The chromatography was carried out on Acquity UPLC BEH C18 (100 × 2.1 mm, 1.7μm) using a mobile phase 0.1% formic acid. The analyses were monitored at 220 nm using a PDA detector. The retention time of the DEM was 7 min. The method was linear in the concentration range of 20-120ppm with a correlation coefficient of 0.999. The method was validated as per ICH guidelines.

Keywords

UPLC, Method Validation, Dabigatran Etexilate Mesylate, ICH guidelines