Open AccessMETHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIES FOR DETERMINATION OF BUMETANIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-UPLC
Author(s) -
Chaitanya Boni,
Raja Sundararajan
Publication year - 2018
Publication title -
international journal of pharmacy and pharmaceutical sciences/international journal of pharmacy and pharmaceutical sciences
Language(s) - English
Resource type - Journals
eISSN - 2656-0097
pISSN - 0975-1491
DOI - 10.22159/ijpps.2018v10i3.23728
Subject(s) - bumetanide , chromatography , dosage form , chemistry , acetonitrile , correlation coefficient , high performance liquid chromatography , hydrolysis , degradation (telecommunications) , repeatability , analytical chemistry (journal) , mathematics , computer science , statistics , organic chemistry , telecommunications , cotransporter , sodium
Objective: The objective of the study was to develop a new, simple, accurate, precise and reproducible RP-UPLC method for the estimation of bumetanide in bulk and pharmaceutical dosage form.Methods: Acquity SB C18, 2 x 100 mm, 1.8 µmm, 5m particle size column with the mobile phase consisting of water: acetonitrile in the ratio of 30:70 v/v were used. The effluents were moniRTat 254 nm and the flow rate was 1.0 ml/minute.Results: The retention time was 0.852 min. Quantitative linearity was obeyed in the concentration range of 12.5 to 75 μg/ml. The correlation coefficient for bumetanide was found to be 0.999. Recovery and assay studies of bumetanide were within 99 to 102%, indicating that the proposed method can be adaptable for quality control analysis of bumetanide. The % RSD for precision and accuracy of the method was found to be less than 2%. Bumetanide was subjected to stress environment of degradation in aqueous solutions including oxidation, hydrolysis, thermal and photolysis degradation.Conclusion: Proposed method was found to be simple, accurate, precise, and quick and can be used for regular analysis. This condition was applied to tablet dosage form. The statistical parameters and recovery studies were reported.