Method development and validation of nicardipine hydrochloride in bulk and formulation using UV spectrophotometric method

Amala Mateti, Kiran Aarelly, M

Abstract

The present study describes a simple, accurate, pre cise, specific and highly sensitive method for the determination of Nicardipine Hydrochloride present in pharmaceutica l dosage forms. The method is validated for the det ermination of Nicardipine Hydrochloride in bulk and tablet do sage form. The solvent used was acetonitrile: water (50:50) and the λ max or the absorption maxima of the drug was found to be 235nm. A linear response was observed in the range of 5-25 μ g/ml with a regression coefficient of 0.999. The li near regression equation obtained by least square regression method were y=0.249X+0.008, where y is t he absorbance and x is the concentration of the pur e drug solution. The. The method was validated for several parameters like accuracy, precision as per ICH gui delines. The values of relative standard deviation and % recover y were found to be satisfactory, indicating that th e proposed method is precise and accurate and hence can be use d for the routine analysis of Nicardipine Hydrochlo ride in bulk and pharmaceutical formulation.

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