Development and Validation of an Innovative Method for the Determination of Cefadroxil Monohydrate in Capsules

摘要

This paper describes the development and validation of an innovative method using Fourier Transform Infrared (FT-IR) transmission spectroscopy for the determination and quantification of cefadroxil monohydrate in capsules. The method was validated with no use of organic solvents and it is in accordance to the International Conference on Harmonisation guidelines, presenting great advantage over other analytical methods, because of the great contribution to the environment, green chemical and pharmaceutical industries. The method can be quantified by measuring the absorbance of the band corresponding to the carbonyl present in the drug molecule, in the region between 1800 and 1700 cm^-1, where it shows accuracy, linearity, precision, robustness and selectivity, being linear over a range of concentrations from 1.5 to 2.5 mg with correlation coefficients of 0.9990 and limit of detection and quantitation of 0.37 and 1.11 mg, respectively. This FT-IR method presents simple execution, low cost analysis and it is environmentally friendly, therefore it is very useful for routine quality control analysis of this drug.