Published:Journal of Chromatographic Science,
ISSN 0021-9665Volume 41, Number 7, August 2003, pp. 371-376
A Validated HPLC Method for the Assay of Xanthone and 3-Methoxyxanthone
in PLGA Nanocapsules
Maribel Teixeira[1],[2], Carlos M.M. Afonso[1], Madalena M.M.M.
Pinto[1], and Carlos Maurício Barbosa[3],[4]
[1]Centro de Estudos de Química Orgânica, Fitoquímica e
Farmacologia da Universidade do Porto-Faculdade de Farmácia do Porto,
R. Aníbal
Cunha, 164, 4050 Porto, Portugal;
[2]Instituto Superior de Ciências da
Saúde-Norte, R. Central de Gandra, 1317, 4580 Paredes, Portugal;
[3]CTMUP/
Faculdade de Farmácia do Porto, R. Aníbal Cunha, 164, 4050 Porto,
Portugal;
[4]CETMED-Centro Tecnológico do Medicamento, R. do Passeio
Alegre, 840, 4150- 574 Porto, Portugal
This work relates the development and validation of a simple reversed-phase
high-performance liquid chromatographic (HPLC) method for the analysis of xanthone
(XAN) and 3-methoxyxanthone (3-MeOXAN) in poly(d,l-lactide-co-glycolide) (PLGA)
nanocapsule formulations. This method does not require any complex sample extraction
procedure. Chromatographic separation is made with a reversed-phase C18 column,
using methanol–water (90:10, v/v) as a mobile phase at a flow rate of
1 mL/min. Identification is made by UV detection at 237 nm. The isocratic system
operates at ambient temperature and requires 7 min of chromatographic time.
The developed method is statistically validated according to United States
Pharmacopoeia 25 and International Conference on Harmonization guidelines for
its specificity, linearity, accuracy, and precision. The assay method proposed
in this study is specific for XAN and 3-MeOXAN in the presence of nanocapsule
excipients. Diode-array analyses confirm the homogeneity of XAN and 3-MeOXAN
peaks in stressed conditions. Standard curves are linear (r > 0.999) over
the concentration range of 0.4–2.5 and 1.0–5.8 µg/mL for
XAN and 3-MeOXAN, respectively. Recovery from nanocapsules ranges from 99.6%
to 102.8% for XAN and 98.8% to 102.4% for 3-MeOXAN. Repeatability (intra-assay
precision) is acceptable with relative standard deviation values of 1.2% for
XAN and 0.3% for 3-MeOXAN.
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