Affiliation:
1. Department of Pharmaceuticals, School of Pharmaceutical Sciences, Universidade Estadual Paulista (UNESP), Araraquara, SP, Brazil
Abstract
Background:
A simple, eco-friendly and low-cost Infrared (IR) method was developed and
validated for the analysis of Cefepime Hydrochloride (CEF) in injectable formulation. Different from
some other methods, which employ organic solvents in the analyses, this technique does not use these
types of solvents, removing large impacts on the environment and risks to operators.
Objective:
This study aimed at developing and validating a green analytical method using IR spectroscopy
for the determination of CEF in pharmaceutical preparations.
Methods:
The method was validated according to ICH guidelines and the quantification of CEF was
performed in the spectral region absorbed at 1815-1745 cm-1 (stretching of the carbonyl group of β-
lactam ring).
Results:
The validated method showed to be linear (r = 0.9999) in the range of 0.2 to 0.6 mg/pellet of
potassium bromide, as well as for the parameters of selectivity, precision, accuracy, robustness and
Limits of Detection (LOD) and Quantification (LOQ), being able to quantify the CEF in pharmaceutical
preparations. The CEF content obtained by the IR method was 103.86%.
Conclusion:
Thus, the method developed may be an alternative in the quality control of CEF sample
in lyophilized powder for injectable solution, as it presented important characteristics in the determination
of the pharmaceutical products, with low analysis time and a decrease in the generation of toxic
wastes to the environment.
Funder
São Paulo Research Foundation - FAPESP
Publisher
Bentham Science Publishers Ltd.
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