IQUIR   05412
INSTITUTO DE QUIMICA ROSARIO
Unidad Ejecutora - UE
artículos
Título:
Simultaneous acquisition of the dissolution curves of two active ingredients in a binary pharmaceutical association, employing an on-line circulation system and chemometrics-assistance
Autor/es:
MAGGIO, R. M.; RIVERO, M. A.; KAUFMAN, TEODORO S
Revista:
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Editorial:
ELSEVIER SCIENCE BV
Referencias:
Lugar: Amsterdam; Año: 2013 vol. 72 p. 51 - 58
ISSN:
0731-7085
Resumen:
The
association of an on-line circulation system with a chemometrics-assisted UV
detection strategy is described as a useful system to continuously monitor the
dissolution of a pharmaceutical preparation containing two active ingredients,
and as a tool for the simultaneous determination of the dissolution curves and
dissolution profiles of the latter. Multivariate curve resolution with
alternating least squares (MCR-ALS) was used as the chemometric tool to
quantitate the analytes, while the hydrochlorothiazide-bisoprolol fumarate
(HCT-BIS) association was employed as a model for method development. The experiments
were carried out with a dissolution tester configured as apparatus II
(paddles), under USP 32 official conditions. The suitability of the calibration
procedure for quantitating the dissolved drugs was assessed according to ICH
guidelines, with regards to linearity in the working range, specificity,
accuracy and precision. Figures of merit, including limits of detection and
quantitation were also determined, as well as the method´s robustness with
regards to detection wavelength range. The system was able to consistently
provide very reproducible dissolution curves of commercial tablets, which were
statistically similar to those furnished by a manual sampling technique,
followed by HPLC analysis. To demonstrate the usefulness of the proposed
system, the dissolution profiles of different lots of HCT-BIS tablets were
acquired and three of them were conveniently compared at a 31 data point level,
employing the f1 and f2 ("difference" and "similarity")
indexes. Use of multiple data points for comparison ensured reliability of the
results.