Development and Validation of the Quantitative Analysis of Ampicillin Sodium in Powder for Injection by Fourier-transform Infrared Spectroscopy (FT-IR)

摘要

This paper describes the validation of an innovative analytical method for ampicillin sodium in powder for injection quantification, using Fourier-transform infrared (FT-IR) transmission spectroscopy. This technique does not use organic solvents, which is one great advantage over the most common analytical methods. This fact contributes to minimize the generation of organic solvent waste by the industry and thereby reduces the impact of its activities on the environment. The method involved absorbance measurements of the band corresponding to one of the carbonyl groups in the molecule, centered in the region between 1800 and 1700 cm^-1. The method was validated according to ICH guidelines, showing to be linear (r = 0.9993), precise, accurate and robust, over a concentration range from 1.0 to 3.0 mg. The validated method is able to quantify ampicillin sodium in powder for injection preparation and can be used as an environmentally friendly alternative for the routine analysis in quality control.