METHOD DEVELOPMENT AND VALIDATION OF HYDRALAZINE HYDROCHLORIDE BY USING UV AND RP-HPLC
Journal Title: Indo American Journal of Pharmaceutical Research - Year 2017, Vol 7, Issue
Abstract
A simple, rapid, precise and highly selective spectrophotometric method was developed for estimation of Hydralazine Hydrochloride in tablet dosage form. This method, involves the measurement of absorbances of Hydralazine at the wavelength of 262nm. Distilled water was used as solvent. Linearity was observed in the concentration range of 2-20?g/ml. The accuracy of the method was found to be 99.2%. The LOD and LOQ of Hydralazine was found to be 0.051?g/ml and 0.16?g/ml. The method showed good reproducibility and recovery with % RSD less than 2. A selective, precise, isocratic and accurate reverse phase high performance liquid chromatographic method was developed for the determination of Hydralazine Hydrochloride in the tablet dosage form. A chromatographic separation was achieved on reverse phase BDS Hypersil C18 column (250 ×4.6 mm, 5?). The mobile phase consists of mixture of Methanol and Acetonitrile. The flow rate was 1.2ml/min and the effluents were monitored at the wavelength of 270nm.The retention time of Hydralazine HCl was found to be 2.58min respectively. Hydralazine HCl was found to be linear in the range of 0.5 to 4 ?g/ml with the recoveries of 98 % and 100.5 %.The method was validated as per ICH guidelines. In proposed methods good results were obtained and can be applied for the routine analysis of formulation.
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