RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DOXYLAMINE AND PYRIDOXINE IN PURE AND PHARMACEUTICAL DOSAGE FORM

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Pyridoxine and Doxylamine, in its pure form as well as in tablet dosage form. Chromatography was carried out on an Sunfire C18 (4.6×250mm) 5µ column using a mixture of Water and Acetonitrile (60:40% v/v) as the mobile phase at a flow rate of 0.9ml/min, the detection was carried out at 220nm. The retention time of the Doxylamine and Pyridoxine was 3.0, 3.8±0.02min respectively. The method produce linear responses in the concentration range of 5-25µg/ml of Doxylamine and 5-25µg/ml of Pyridoxine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Doxylamine, Pyridoxine, RP-HPLC, validation.