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

Nadal JM, Toledo Mda G, Pupo YM, Padilha de Paula J, Farago PV, Zanin SM - J Anal Methods Chem (2015)

Bottom Line: 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.Precision (intraday and interday) was demonstrated by a relative standard deviation lower than 2.0%.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.

View Article: PubMed Central - PubMed

Affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmacy, Federal University of Paraná, 632 Lothário Meissner Avenue, 80210-170 Curitiba, PR, Brazil.

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.

No MeSH data available.


Related in: MedlinePlus

Representative HPLC chromatogram of ferulic acid standard (40 μg/mL) in methanol : water adjusted to pH 3.0. Mobile phase: methanol : water adjusted to pH 3.0 using orthophosphoric acid (48 : 52 v/v); flow rate: 1.0 mL/min; detection wavelength: 320 nm; column temperature: 25 ± 2°C; and injection volume: 10 μL.
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fig2: Representative HPLC chromatogram of ferulic acid standard (40 μg/mL) in methanol : water adjusted to pH 3.0. Mobile phase: methanol : water adjusted to pH 3.0 using orthophosphoric acid (48 : 52 v/v); flow rate: 1.0 mL/min; detection wavelength: 320 nm; column temperature: 25 ± 2°C; and injection volume: 10 μL.

Mentions: Therefore, additional experiments were carried out removing acetonitrile and using acetic acid and orthophosphoric acid as acidifying agents at different pH values. The mobile phase composed by methanol : water adjusted to pH 3.0 using orthophosphoric acid (48 : 52 v/v) provided a lower tailing and a more symmetric peak for FA with a lower retention time (theoretical plates = 1253, k′ = 3.77, and tail factor = 1.3). The peak was detected at 4.86 min (Figure 2) which is very suitable for routine analyses.


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

Nadal JM, Toledo Mda G, Pupo YM, Padilha de Paula J, Farago PV, Zanin SM - J Anal Methods Chem (2015)

Representative HPLC chromatogram of ferulic acid standard (40 μg/mL) in methanol : water adjusted to pH 3.0. Mobile phase: methanol : water adjusted to pH 3.0 using orthophosphoric acid (48 : 52 v/v); flow rate: 1.0 mL/min; detection wavelength: 320 nm; column temperature: 25 ± 2°C; and injection volume: 10 μL.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4446543&req=5

fig2: Representative HPLC chromatogram of ferulic acid standard (40 μg/mL) in methanol : water adjusted to pH 3.0. Mobile phase: methanol : water adjusted to pH 3.0 using orthophosphoric acid (48 : 52 v/v); flow rate: 1.0 mL/min; detection wavelength: 320 nm; column temperature: 25 ± 2°C; and injection volume: 10 μL.
Mentions: Therefore, additional experiments were carried out removing acetonitrile and using acetic acid and orthophosphoric acid as acidifying agents at different pH values. The mobile phase composed by methanol : water adjusted to pH 3.0 using orthophosphoric acid (48 : 52 v/v) provided a lower tailing and a more symmetric peak for FA with a lower retention time (theoretical plates = 1253, k′ = 3.77, and tail factor = 1.3). The peak was detected at 4.86 min (Figure 2) which is very suitable for routine analyses.

Bottom Line: 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.Precision (intraday and interday) was demonstrated by a relative standard deviation lower than 2.0%.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.

View Article: PubMed Central - PubMed

Affiliation: Postgraduate Program in Pharmaceutical Sciences, Department of Pharmacy, Federal University of Paraná, 632 Lothário Meissner Avenue, 80210-170 Curitiba, PR, Brazil.

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.

No MeSH data available.


Related in: MedlinePlus