A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF DABIGATRAN ETEXILATE MESYLATE IN CAPSULES


D. Vijay Kumar, K. Balaraju, A. Ashok Kumar

Abstract


Objective: To develop a rapid, sensitive, accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Dabigatran etexilate mesylate in capsules.

Methods: The optimized method uses a reverse phase column, Waters Symmetry C18 (250 X 4.6 mm; 5μ), a mobile phase of tri ethylammonium phosphate buffer (pH 2.5):acetonitrile in the proportion of 40:60 v/v, flow rate of 1.0 ml/min and a detection wavelength of 313 nm using a UV detector.

Results: The developed method resulted in Dabigatran etexilate mesylate eluting at 2.44 min. It exhibited linearity in the range 15-45μg/ml. The precision is exemplified by relative standard deviation of 0.05%. Percentage mean recovery was found to be in the range of 98‐102, during accuracy studies. The limit of detection (LOD) and limit of quantitation (LOQ) was found to be 39.19μg/ml and 118.88μg/ml respectively.

Conclusion: A sensitive, rapid, accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of Dabigatran etexilate mesylate in capsules as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.

 


Keywords


RP‐HPLC, Dabigatran etexilate mesylate, Method development, Validation

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References


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About this article

Title

A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF DABIGATRAN ETEXILATE MESYLATE IN CAPSULES

Keywords

RP‐HPLC, Dabigatran etexilate mesylate, Method development, Validation

Date

02-09-2015

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 7, Issue 10, 2015 Page: 352-356

Online ISSN

0975-1491

Statistics

340 Views | 188 Downloads

Authors & Affiliations

D. Vijay Kumar
Vijaya College of Pharmacy
India

K. Balaraju
Vijaya College of Pharmacy
India

A. Ashok Kumar
Department of Pharmaceutical Analysis and Quality Assurance, Vijaya College of Pharmacy, Munaganur (village), Hayathnagar (Mandal), Hyderabad 501511, India
India


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