A MODIFIED LIQUID CHROMATOGRAPHIC METHOD DEVELPOMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE IN BULK AND TABLET DOSAGE FORMAbstract
A simple, precise, accurate, reproducible and economical reverse phase liquid chromatography method was developed and validated for the quantitative simultaneous estimation of Bisoprolol Fumarate and Hydrochlorothiazide in bulk and marketed formulations. Estimation of drugs in this combination was done with a C18 column Kromasil 100-5C18 column [250mm x 4.6mm].using mobile phase of composition Acetonitrile and phosphate buffer (40:60 v/v, pH 3).The flow rate was 1 ml/min and the effluents were monitored at 228 nm. The retention time of Bisoprolol Fumarate and Hydrochlorothiazide were 3.3 min and 6.25 min respectively. The method was found to be linear over a concentration range of 20-100 mg/ml for both Bisoprolol Fumarate and Hydrochlorothiazide. The established method proved as reproducible one with a %RSD value of less than 2 and having the robustness and accuracy within the specified limits. Assay of marketed formulation was determined and find with 98.1% and 97.6% for Bisoprolol Fumarate and Hydrochlorothiazide respectively. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully employed in the estimation of commercial formulations. This liquid chromatographic method can be applied for the qualitative and quantitative determination of selected drugs by the modern chemist.
D. Suryanarayana Raju*, S. Vidyadhara, B. Venkateswara Rao and D. Madhavi
Department of Pharmaceutical Analysis, Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chandramoulipuram, Chowdavaram, Guntur, Andhra Pradesh, India
02 February, 2016
09 April, 2016
13 April, 2016
01 July 2016