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Abstract

VALIDATED AND STABILITY INDICATING LIQUID CHROMATOGRAPHY METHOD FOR QUANTIFICATION OF BISOPROLOL FUMARATE IN TABLET DOSAGE FORM

Madhusudhanareddy Induri, Bhagavan Raju M and Rajendra Prasad Y

A simple and accurate liquid chromatographic method was developed and validated for the analysis of bisoprolol fumarate in tablets. Chromatographic separation was achieved on a C18 column utilizing a mobile phase of buffer/acetonitrile (75:25, v/v, pH 5.6) at a flow rate of 1.0 mL/min. The separation was performed at room temperature. Detection was carried out at 226 nm, using a diode array detector. The developed method was statistically validated for the linearity, accuracy, limit of detection, limit of quantitation, precise and specificity. The specificity of the method was ascertained by forced degradation studies; the degraded products were well separated from the analyte. The mean recovery for bisoprolol fumarate from tablets ranged between 99.87-100.43%. The proposed method is also found to be precise and robust. The method can be used for routine quality control analysis.


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