alexa Validated stability - indicating high performance liquid chromatographic assay method for the determination of Dabigatran E texilate M esylate
Chemical Engineering

Chemical Engineering

Journal of Chromatography & Separation Techniques

Author(s): P radeep G Shelke, AV Chandewar

Abstract Share this page

Dabigatran Etexilate Mesylate was subjected to different ICH recommended stress conditions. Degradation of drug occurs almost in all conditions (hydrolytic, oxidative and photolytic) while mild degradation was seen with thermal stress. A validated stability - indicating HPLC method was developed for the analysis of drug in presence of its degradation products. The stressed samples of drug were analyzed using Kinetex C - 8 column (5μ, 250×4.6 mm) column using a mobile phase composed of methanol: water, which was delivered initially in the r atio of 70:30 (v/v) for 1 min, then changed to 90:10 (v/v) for next 9 min and finally equilibrated back to initial composition 70:30 (v/v) from 11 to 20 min. The flow rate was maintained at 1.0 ml/min and detection was carried out at 230 nm using 996 PDA d etector. The method was validated in terms of linearity, accuracy, precision specificity and selectivity.

  • To read the full article Visit
  • Open Access
This article was published in Research Journal of Pharmaceutical, Biological and Chemical Sciences and referenced in Journal of Chromatography & Separation Techniques

Recommended Conferences

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords