title: A Stability-Indicating HPLC-DAD Method for Determination of Ferulic Acid into Microparticles: Development, Validation, Forced Degradation, and Encapsulation Efficiency.
abstract: A simple stability-indicating HPLC-DAD method was validated for the determination of ferulic acid (FA) in polymeric microparticles. Chromatographic conditions consisted of a RP C18 column (250 mm × 4.60 mm, 5 μm, 110 Å) using a mixture of methanol and water pH 3.0 (48 : 52 v/v) as mobile phase at a flow rate of 1.0 mL/min with UV detection at 320 nm. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of quantification, limit of detection, accuracy, precision, and robustness provided suitable results regarding all parameters investigated. The calibration curve was linear in the concentration range of 10.0-70.0 μg/mL with a correlation coefficient >0.999. Precision (intraday and interday) was demonstrated by a relative standard deviation lower than 2.0%. Accuracy was assessed by the recovery test of FA from polymeric microparticles (99.02% to 100.73%). Specificity showed no interference from the components of polymeric microparticles or from the degradation products derived from acidic, basic, and photolytic conditions. In conclusion, the method is suitable to be applied to assay FA as bulk drug and into polymeric microparticles and can be used for studying its stability and degradation kinetics.
authors.affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmacy, Federal University of Paraná, 632 Lothário Meissner Avenue, 80210-170 Curitiba, PR, Brazil.
authors.forename: Jessica Mendes
authors.identifier: 0000-0002-2419-2110
authors.initials: JM
authors.lastname: Nadal
authors.affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmacy, Federal University of Paraná, 632 Lothário Meissner Avenue, 80210-170 Curitiba, PR, Brazil.
authors.forename: Maria da Graça
authors.initials: Mda G
authors.lastname: Toledo
authors.affiliation: Postgraduate Program in Dentistry, Department of Dentistry, State University of Ponta Grossa, 4748 Carlos Cavalcanti Avenue, 84030-900 Ponta Grossa, PR, Brazil.
authors.forename: Yasmine Mendes
authors.initials: YM
authors.lastname: Pupo
authors.affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmaceutical Sciences, State University of Ponta Grossa, 4748 Carlos Cavalcanti Avenue, 84030-900 Ponta Grossa, PR, Brazil.
authors.forename: Josiane
authors.initials: J
authors.lastname: Padilha de Paula
authors.affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmaceutical Sciences, State University of Ponta Grossa, 4748 Carlos Cavalcanti Avenue, 84030-900 Ponta Grossa, PR, Brazil.
authors.forename: Paulo Vitor
authors.identifier: 0000-0002-9934-4027
authors.initials: PV
authors.lastname: Farago
authors.affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmacy, Federal University of Paraná, 632 Lothário Meissner Avenue, 80210-170 Curitiba, PR, Brazil.
authors.forename: Sandra Maria Warumby
authors.initials: SM
authors.lastname: Zanin