Development and validation of RP- HPLC method for the estimation of dabigatran etexilate mesylate (DEM) in bulk form

Authors

  • N.Madhavi Latha Department of Pharmaceutical Analysis & Quality Assurance, A. U College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India. 530 003
  • P.Supriya Department of Pharmaceutical Analysis & Quality Assurance, A. U College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India. 530 003
  • G.V.Ramana Department of Pharmaceutical Analysis & Quality Assurance, A. U College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India. 530 003
  • K.B.V.Rohith Department of Pharmaceutical Analysis & Quality Assurance, A. U College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India. 530 003
  • G.Chaitanya Department of Pharmaceutical Analysis & Quality Assurance, A. U College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India. 530 003
  • A.K.M Pawar Department of Pharmaceutical Analysis & Quality Assurance, A. U College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India. 530 003

DOI:

https://doi.org/10.61096/ijpar.v5.iss1.2016.141-147

Keywords:

HPLC, Method Validation, Dabigatran Etexilate Mesylate, ICH guidelines.

Abstract

The RP- HPLC method was developed and validated for the determination of Dabigatran Etexilate Mesylate (DEM) in bulk form. The chromatography was carried out on Unisol C18 (4.6 × 150 mm, 3μm) using a mobile phase of methanol and ammonium acetate buffer in the ratio of 90:10, at a flow rate of 1 ml/minute. The analytes were monitored at 226 nm using a PDA detector. The retention time of the DEM was 2.52 min. The method was linear in the concentration range of 20 -100 µg/ml with a correlation coefficient of 0.999. The method was validated as per ICH guidelines.

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Published

2016-02-13

How to Cite

N.Madhavi Latha, P.Supriya, G.V.Ramana, K.B.V.Rohith, G.Chaitanya, & A.K.M Pawar. (2016). Development and validation of RP- HPLC method for the estimation of dabigatran etexilate mesylate (DEM) in bulk form. IJPAR JOURNAL, 5(1), 141–147. https://doi.org/10.61096/ijpar.v5.iss1.2016.141-147

Issue

Vol. 5 No. 1 (2016): 2016 Volume - 5 Issue - 1

Section

Articles