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

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