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Abstract

DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR ESTIMATION OF DARIFENACIN HYDROBROMIDE IN DOSAGE FORM USING ?-NAPHTHOL

N.Raghavendra Babu*, K. Akshitha Reddy, Y.Padmavathi, P.Ravi Kumar, D.Venkat Vijaya

Department of Pharmaceutical analysis, G.Pulla Reddy college of Pharmacy, Mehdipatnam, Hyderabad, India.

ABSTRACT

A sensitive visible spectrophotometric method was developed and validated for the estimation of darifenacin hydrobromide in the pharmaceutical dosage form using diazo coupling reaction with the chromogenic reagent β naphthol forms a yellow coloured diazo complex with darifenacin hydrobromide. Analysis was carried out at its λmax 384nm and the method was validated according to USFDA guidelines. The method obeys the Beer’s law in the concentration range of 40-140ng/ml. The correlation coefficient was found to be 0.999. As the method was sensitive, it was successfully applied to the analysis of darifenacin hydrobromide in spiked rat plasma.

Keywords: ?-naphthol, darifenacin hydrobromide, spectrophotometric determination and USFDA guidelines.


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