Abstract

A NOVELVALIDATED STABILITY INDICATING RP-LC METHOD FOR SIMULTANEOUS QUANTITATIVE ESTIMATION OF HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE IN BULK DRUG AND COMBINED TABLET DOSAGE FORM

Leela Madhuri Pola* and Gowri Sankar D

ABSTRACT

The current study focussed on RP-HPLC method development and subsequent validation for simultaneous quantitative determination of Hydralazine hydrochloride (HLZ) and Isosorbide dinitrate (ISB) in combined tablet dosage form. The developed method was applied to accelerated degradation studies successfully to verify the utility of established procedure. The degraded products were distinctly separated from Hydralazine hydrochloride and Isosorbide dinitrate with high degree of resolution without any interference, indicating specificity of the method. Chromatographic separation was achieved in isocratic mode at ambient temperature on a hypersil (BDS) C18 column with dimensions 150X4.6 mm and 5μ particle size using mobile phase comprising of potassium dihydrogen orthophosphate (0.01 M, pH 5.0 adjusted with dilute ammonia solution) and acetonitrile in the proportions of 50:50 V/V. The eluents were detected at iso absorptivity wavelength of 235 nm in total run time of 10min. The flow rate was maintained 1.0 mL/min and the optimised volume of injection was 20μL. The method is validated with respect to linearity, precision, accuracy, robustness, ruggedness and system suitability parameters as per ICH guidelines.

Keywords: Hydralazine hydrochloride, Isosorbide dinitrate, Forced degradation studies, RP-HPLC, Isocratic, Validation, ICH.