Validation of a Spectrophotometric Analytical Method for the Quantitative Determination of Adrenaline in Injectable Pharmaceutical Formulations

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

¹Sección de Fisicoquímica, FES Cuautitlán-UNAM, Departamento de Ciencias Químicas. Av. Primero de Mayo s/n, Cuautitlán Izcalli, Edo. Mex. México C.P. 54700

²Sección de Química Analítica, FES Cuautitlán-UNAM, Departamento de Ciencias Químicas. Av. Primero de Mayo s/n, Cuautitlán Izcalli, Edo. Mex. México C.P. 54700

Cite this paper:
Carlos Montaño-Osorio, Dalia Bonilla-Martínez, Martha Angélica Villegas-González and Adolfo Eduardo Obaya Valdivia. Validation of a Spectrophotometric Analytical Method for the Quantitative Determination of Adrenaline in Injectable Pharmaceutical Formulations. American Journal of Pharmacological Sciences. 2021; 9(1):40-45. doi: 10.12691/ajps-9-1-4

Abstract

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:
Keywords: adrenaline validation spectrophotometry injectable adrenaline formulations

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