Carlos Montaño-Osorio^1,, Dalia Bonilla-Martínez², Martha Angélica Villegas-González², Adolfo Eduardo Obaya Valdivia^1,

A spectrophotometric method is validated for the quantification of adrenaline in injectable pharmaceutical forms by means of the quantitative formation of the iron(III)-adrenaline complex, obtaining the validation parameters at the maximum absorption of the complex (432 nm and 648 nm), determining that the best wavelength to perform the quantification is 648 nm because it satisfies the validation parameters and is the most sensitive. It is shown that the 648 nm method has a linear relationship in an adrenaline concentration range of 1.1704 10^–4 M to 1.1704 10^–3 M, through the analysis of the confidence intervals for the slope and the ordinate at the origin, as well as the evaluation of the residuals of the regression. The limits of detection and quantification are 3.5267 10^–6 M and 2.8200 10^–5 M, respectively, for the calibration curves at 648 nm. The method is specific, reproducible, and accurate at 648 nm. The method is shown to be robust in the pH range of 4.70 to 5.15. For the determination of adrenaline at 648 nm, it is possible to use aqueous standards for the construction of calibration curves, without the need to add placebo because a confidence interval of the slope is obtained for the recovery curve of 0.9982–1.0007, so there is no matrix effect.

Keywords: adrenaline, validation, spectrophotometry, injectable adrenaline formulations