UV SPECTROPHOTOMETRIC ASSAY METHOD DEVELOPMENT AND VALIDATION OF DABIGATRAN ETEXILATE IN CAPSULES
Objective: To develop a simple and a cheap UV spectrophotometric method for the quantitative estimation of Dabigatran etexilate in capsules and validate as per ICH guidelines.
Methods: The optimized method uses triethyl ammonium phosphate aqueous solution (pH 2.5) as a solvent for the estimation of assay of Dabigatran etexilate in capsules at a wavelength of 325 nm.
Results: The developed method resulted in Dabigatran etexilate exhibiting linearity in the range 5-15Î¼g/ml. The assay precision is exemplified by relative standard deviation of 1.07%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. Method was found to be robust with respect to wavelength and pH of the solvent.
Conclusion: A simple and a cheap UV spectrophotometric method was developed and validated for the quantitative estimation of Dabigatran etexilate in capsules as per ICH guidelines and hence it can be used for routine analysis in various pharmaceutical industries.
2. Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, Placebo-Controlled, Crossover study in healthy subjects. Circulation 2011;124(14):1573-9.
3. Ankit P, Sharad K, Ashim KS, Aarti Z, Seth AK. Spectrophotometric method for estimation of Dabigatran etexilate in bulk and its pharmaceutical dosage form. Pharma Sci Monit 2014;5(2):31-9.
4. Zhe-Yi Hu, Robert BP, Vanessa LH, Casey L. Conventional liquid chromatography/triple quadrupole mass spectrometry based metabolite identification and semi-quantitative estimation approach in the investigation of in vitro Dabigatran etexilate metabolism. Anal Bioanal Chem 2013;405(5):1695-704.
5. Xavier D, Julie M, Laporte S, Patrick M, Thierry B. UPLC MS/MS assay for routine quantification of Dabigatran-a direct thrombin inhibitor in human plasma. J Pharm Biomed Anal 2012;25(58):152-6.
6. Mrinalini CD, Rupesh AB. Development and validation of stability-indicating RP-HPLC method for estimation of Dabigatran etexilate. J Adv Sci Res 2014;5(3):39-44.
7. Bernardi RM, Froehlich PE, Bergold AM. Development and validation of a stability indicating liquid chromatography method for the determination of Dabigatran etexilate in capsules. J AOAC Int 2013;96(1):37-41.
8. Sekhar reddy BRC, Vijaya bhaskar rao N. A stability indicating RP-HPLC method for estimation of Dabigatran in pure and pharmaceutical dosage forms. SPJPBS 2014;2(1):80-92.
9. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures: Text and Methodology ICH Q2 (R1);2005.