Journal :   Asian Journal of Research in Chemistry

Volume No. :   11

Issue No. :  5

Year :  2018

Pages :   787-790

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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



Address:   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
1Department of Medicinal Chemistry, GVK Biosciences Pvt. Ltd, IDA Mallapur, Hyderabad, Telangana, India-500076
2Department of Engineering Chemistry, Andhra University, Visakhapatnam, A.P., India-530003
*Corresponding Author
DOI No: 10.5958/0974-4150.2018.00138.4

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.
Cite:
B. V. Narasimha Raju Katari, V.V.S.R.N. Anji Karun Mutha, Muralidharan Kaliyaperumal, Chidananda Swamy Rumalla, Ragu Babu Korupolu, Annapurna Nowduri. Method Development and Validation of RP-UPLC method for the determination of Dabigatran Etexilate Mesylate in API. Asian J. Research Chem. 2018; 11(5): 787-790
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