A validated kinetic method for determination of nortriptyline hydrochloride in pharmaceutical formulations

Abstract

The objective of this research is to develop a simple, sensitive and validated kinetic spectrophotometric method for the determination of nortriptyline hydrochloride in pure and pharmaceutical formulations. The method is based on derivatization of drug with1-chloro-2,4-dinitrobenzene (CDNB) in dimethyl sulfoxide (DMSO) medium at room temperature (30 1 ⁰ C). The reaction was followed spectrophotometrically by measuring the increase in absorbance at 390 nm as a function of time. Under the optimized experimental conditions, Beers law obeyed in the concentration range of 20-100 g/ml for both initial rate and fixed time methods. The limits of quantitation are 2.975 and 3.680 g/ml for initial rate and fixed time methods, respectively. The method has been successfully applied to the determination of nortriptyline in pharmaceutical formulations. Statistical comparison of the results with the reference method shows excellent agreement and indicates no significant difference in accuracy and precision.