A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF DABIGATRAN ETEXILATE MESYLATE IN CAPSULES
Keywords:
Nil, Dabigatran etexilate mesylate, Method development, ValidationAbstract
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 98â€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.
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References
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