A NOVEL REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF DROTAVERINE HYDROCHLORIDE, ETHAMSYLATE, AND TRANEXAMIC ACID IN TABLET DOSAGE FORM
Objective: The objective of this study was to develop and validate a simple, rapid, accurate, and precise reversed-phase high-performance liquid chromatographic method (RP-HPLC) for simultaneous estimation of drotaverine hydrochloride, ethamsylate, and tranexamic acid in tablet dosage form.
Methods: The chromatographic separation was achieved using stationary phase C18 shim-pack GIST (150 mm Ã—4.6 mm, 5 Î¼) column and mobile phase consists of methanol:potassium dihydrogen phosphate buffer (pH 3.0 adjusted using orthophosphoric acid) in a ratio of 30:70 v/v, with a flow rate of 1 ml/min and ultraviolet detection at 220 nm.
Results: The retention time of tranexamic acid, ethamsylate, and drotaverine hydrochloride was found to be 3.6, 4.0, and 5.0 min, respectively. The developed method was validated for linearity, accuracy, precision, and robustness according to the international conference on harmonization guidelines. The method was found to be linear over the tested concentration range of 48â€“112 Î¼g/ml for drotaverine hydrochloride, 150â€“350 Î¼g/ml for ethamsylate, and 150â€“350 Î¼g/ml for tranexamic acid. Mean percentage recoveries were found to be 99.59 for drotaverine hydrochloride, 99.27 for ethamsylate, and 99.71 for tranexamic acid. The correlation coefficient for all components was found to be more than 0.999.
Conclusion: A novel RP-HPLC method was developed and validated for simultaneous for the estimation of drotaverine hydrochloride, ethamsylate, and tranexamic acid to their commercially available tablet dosage form.
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