ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF ISOSORBIDE DINITRATE AND HYDRALAZINE HCL IN TABLET DOSAGE FORM BY RP-HPLC
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 5
Abstract
ABSTRACT A simple, precise, rapid, specific and accurate reverse phase high performance liquid chromatography method was developed for simultaneous estimation of Isosorbide Dinitrite and Hydralazine HCl in pharmaceutical dosage form. Chromatographic separation was performed on Agilant Zorbax (C18) (4.6mm x 250mm, 5m) column, with mobile phase comprising of mixture of buffer (pH6.5, adjusted with potassium dihydrogen phosphate), acetonitrile in the ratio of 70:30 v/v, at the flow rate 0.8 ml/min. The detection was carried out at 274 nm. The retention times of Isosorbide Dinitrite and Hydralazine HCl were found to be 3.6 and 2.7 mins respectively with a run time of 6 mins, theoretical levels for Isosorbide Dinitrite and Hydralazine HCl were 8055 and 7525 respectively, with a resolution of 6.57. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of Isosorbide Dinitrite was found in the range of 50-150 μg/mL and that for Hydralazine HCl was found to be 50-150 μg/mL. The correlation coefficient for Isosorbide Dinitrite and Hydralazine HCl were 1 and 0.999 respectively. The LOD values for Isosorbide Dinitrite and Hydralazine HCl were 2.95 and 2.88 μg/mL respectively. The LOQ values for Isosorbide Dinitrite and Hydralazine HCl were and 9.8 and 9.6 μg/mL respectively. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for simultaneous estimation of Isosorbide Dinitrite and Hydralazine HCl tablet dosage form. Keywords: Isosorbide Dinitrate, Hydralazine HCl, RP-HPLC, Validation.
Authors and Affiliations
G. Santhosh*, G. Nagasowjanya, A. Ajitha1, Dr. V. UmaMaheshwaraRao
Keywords
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