Validación de métodos analíticos aplicables al control de calidad y estudio de estabilidad de las gotas nasales de efedrina

Abstract

Aims: The purpose of this study was to validate three analytical methods for quality control and stability study of nasal drops ephedrine hydrochloride.Materials and methods: A liquid chromatographic technique was developed for the quantification of ephedrine hydrochloride and two volumetric techniques for quantification of benzalkonium chloride and edetate disodium, preservatives in the formulation. The evaluated parameters were consistent with internationally established quantitative techniques such as specificity, linearity, accuracy, precision, robustness and limits of detection and quantification.Results: It was demonstrated that the chromatographic method was linear, with a detection limit of 2.62 μg/mL and 5.56 μg/mL as LOQ, selective, accurate, precise and robust. The volumetric method for the benzalkonium chloride was linear, with a detection limit of 0.60 μg/mL and 2.24 μg/mL as the limit of quantification, specific, accurate, precise and robust. The results of the performance evaluation of volumetric method for disodium edetate demonstrated their precision, accuracy and specificity.Conclusions: The chromatographic method for the determination of the active as well as volumetric methods for the quantification of preservatives in the formulation met all the parameters evaluated in the validation, being useful for quality control and stability study.