Identification and characterization of new impurity in Cefotaxime Sodium drug substance
By Monali S. Sali, Ajay L. Barhate, Vinit D. Patil, Ajay S. Bhadoriya, Vishnu P. Choudhari, Bhanudas S. Kuchekar
ABSTRACT
Two simple, precise and economical UV spectrophotometric methods have been developed for the estimation of Ropinirole in pharmaceutical dosage form. Method A applied was area under curve (AUC) in which area under curve was integrated in the wavelength range of 234.36 - 241 nm. Method B involves getting first order derivative spectrum of drug solution and measurement of derivative amplitude at 262.58 nm. Calibration curves were plotted for both methods by using instrumental response at selected wavelength and concentrations of analyte in the solution. Linearity for the detector response was observed in the concentration range of 4-20 μg/ml for both the methods. Two tablet formulations were analyzed and % assay determined was 99.79% – 100.68%. Acuuracy and precision studies were carried out and results were satisfactory. The proposed methods were validated as per ICH analytical method development guidelines. The results of the analysis were validated statistically. Limit of detection and limit of quantitation were determined for both methods.
Keywords : Ropinirole, UV spectrophotometry, derivative spectroscopy, area under curve, tablet formulation
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