UV SPECTROPHOTOMETRIC ASSAY METHOD DEVELOPMENT AND VALIDATION OF DABIGATRAN ETEXILATE IN CAPSULES
Keywords:
UV, Dabigatran etexilate, Method development, ValidationAbstract
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 5-15μg/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.
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References
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