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Abstract

A VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ISOSORBIDE DINITRATE AND HYDRALAZINE IN BULK AND PHARMACEUTICAL DOSAGE FORM.

S. Annapurna Priyadarshika*, Dr. M. Prasada Rao, M. Srikanth

ABSTRACT

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Isosorbide dinitrate and Hydralazine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5μm) column using a mixture of Methanol: TEA pH 4.2 (40:60) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 272 nm. The retention time of the Isosorbide dinitrate and Hydralazine was 2.781, 4.048 ±0.02min respectively. The method produce linear responses in the concentration range of 5-25mg/ml of Isosorbide dinitrate and 9.375-46.875 mg/ml of Hydralazine. 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: Isosorbide dinitrate; Hydralazine; RP-HPLC; Validation; Tablet Dosage forms.


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