Validation and Uncertainty of a Chromatographic Technique for Determining the G-1 and MBr Content in Furvina Lots

Abstract

Furvina (G-1), Dermofural active pharmaceutical ingredient, a topical ointment with antibacterial and antifungal properties is obtained by chemical synthesis and it is accompanied by an impurity, the monobromate (MBr). The objective of this study is to validate a technique by gas chromatography, for determining the G-1 and MBr content in Furvina lots, and calculating the result uncertainty. The parameters: system adequacy, specificity, linearity, precision, accuracy or reliability, and detection and quantification limits, for impurity were evaluated. The technique was found to be specific, linear in the range of 8 mg / L 12 mg / L for G-1 and 0,06mg / L to 0,14 mg / L for MBr, precise and accurate, with a detection limit of 0,0006 mg / L and quantification limit of 0,002 mg / L for the impurity. The expanded uncertainty for G-1, 1,48% and for MBr 0,05% (k = 2; 95% confidence). Keywords: Furvina, gas chromatography, validation, uncertainty.