Limits...
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

HPLC chromatograms (λ = 320 nm) obtained from unloaded and FA-loaded microparticles: M1FA0 (a), M1FA10 (b), M2FA0 (c), and M2FA10 (d).
© Copyright Policy - open-access
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4446543&req=5

fig3: HPLC chromatograms (λ = 320 nm) obtained from unloaded and FA-loaded microparticles: M1FA0 (a), M1FA10 (b), M2FA0 (c), and M2FA10 (d).

Mentions: Specificity was demonstrated by comparing the chromatograms of unloaded and FA-loaded microparticles prepared as per test method. The results showed that there was no interference at the retention time of FA from the other formulation components. In that sense, it is possible to confirm the specificity of the purposed method (Figure 3). Moreover, the photodiode array detector indicated that FA peak was free from interference (purity index > 0.9999).


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)

HPLC chromatograms (λ = 320 nm) obtained from unloaded and FA-loaded microparticles: M1FA0 (a), M1FA10 (b), M2FA0 (c), and M2FA10 (d).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig3: HPLC chromatograms (λ = 320 nm) obtained from unloaded and FA-loaded microparticles: M1FA0 (a), M1FA10 (b), M2FA0 (c), and M2FA10 (d).
Mentions: Specificity was demonstrated by comparing the chromatograms of unloaded and FA-loaded microparticles prepared as per test method. The results showed that there was no interference at the retention time of FA from the other formulation components. In that sense, it is possible to confirm the specificity of the purposed method (Figure 3). Moreover, the photodiode array detector indicated that FA peak was free from interference (purity index > 0.9999).

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