Abstract

SIMULTANEOUS ESTIMATION OF NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DOXYLAMINE AND PYRIDOXINE BY HIGH PERFORMANCE LIQUID HROMATOGRAPHY IN BULK AND MARKETED FORMULATION

Santhosh Illendula* and Gudise Laxmi Prasanna

ABSTRACT

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.