Abstract
Purpose: A simple and sensitive spectrophotometric method in visible region has been developed and validated for quantification of metaxalone (MET) and dabigatran etexilate mesylate (DAB) in their bulk and pharmaceutical dosage forms. Methods: The method is based on the oxidative coupling reaction of 3-methyl-2-benzothiazoline hydrazone (MBTH) with MET and DAB in the presence of ferric chloride to form green coloured chromogen with absorption maximum at 666 nm and 632 nm respectively. Results: Beer’s law is obeyed in concentration range of 4-20 and 1-6 μg/mL for MET and DAB respectively with correlation coefficient of 0.999. Limit of detection and quantification were 0.46 μg/mL and 1.518 μg/mL for MET and 0.0578 μg/mL and 0.298 μg/mL for DAB. When marketed formulations were analyzed, the results obtained by the proposed method were in good agreement with labelled amounts. The developed method was validated statistically as per ICH guidelines. Conclusion: The developed method is simple, sensitive, specific and can be successfully employed in routine analysis of MET and DAB pharmaceutical dosage forms.
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