A Stability-Indicating HPLC-DAD Method for Determination of Ferulic Acid into Microparticles: Development, Validation, Forced Degradation, and Encapsulation Efficiency.

Jessica Mendes Nadal,Yasmine Mendes Pupo,Josiane Padilha De Paula,Maria Da Graça Toledo,Sandra Maria Warumby Zanin,Paulo Vitor Farago

doi:10.1155/2015/286812

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.

Highlights

Ferulic acid (FA; C10H10O4; MW: 194.18 Da) or (E)-3-(4hydroxy-3-methoxy-phenyl)prop-2-enoic acid (Figure 1) is a chemical compound widely found in vegetables which has a low degree of toxicity after oral administration [1]
In order to demonstrate the applicability of the validated method, the encapsulation efficiency (EE) of FA into PHBV/PCL microparticles was calculated using (1) from the HPLC results provided by sample solutions: EE (%) = total drug content − free drug content total drug content
The investigated chromatographic conditions were mainly related to the mobile phase composition

Summary

Introduction

Ferulic acid (FA; C10H10O4; MW: 194.18 Da) or (E)-3-(4hydroxy-3-methoxy-phenyl)prop-2-enoic acid (Figure 1) is a chemical compound widely found in vegetables which has a low degree of toxicity after oral administration [1]. Polymeric microparticles are widely studied carriers for the controlled release application of drugs. The advantages of using such carriers include potential to increase the bioavailability of poorly water-soluble drugs, ability to control the rate and/or the site of drug release, possibility to improve drug stability related to enzymatic, environmental, or chemical/photochemical degradation, elimination of incompatibilities among different drugs, and as a taste-masking approach [14, 15]. Various methods are readily available for microencapsulation of drugs and one of the most commonly used is emulsion/solvent evaporation [16] This procedure can be performed via various protocols and the selection for best option depends on the property of the compounds that are intended to be encapsulated [17].

Materials and Methods

Results and Discussion

Conclusion