IQUIR   05412
INSTITUTO DE QUIMICA ROSARIO
Unidad Ejecutora - UE
artículos
Título:
Development and Validation of an HPLC Method for the Simultaneous Determination of Bromhexine, Chlorpheniramine, Paracetamol and Pseudoephedrine in their Combined Cold Medicine Formulations
Autor/es:
TEODORO S. KAUFMAN; SILVANA E. VIGNADUZZO
Revista:
JOURNAL OF LIQUID CHROMATOGRAPHY AND RELATED TECHNOLOGIES
Editorial:
TAYLOR & FRANCIS INC
Referencias:
Lugar: Londres; Año: 2013 vol. 36 p. 2829 - 2843
ISSN:
1082-6076
Resumen:
A simple and efficient liquid chromatographic method has been developed and validated for
the simultaneous determination of bromhexine, chlorpheniramine, paracetamol, and pseudoephedrine
in common cold medications (tablets and syrups). The separation of the analytes was
achieved within 10 min, employing a mixture of 10mM triethylamine-phosphoric acid buffer
(pH 4.0) and MeOH (35:65, v=v) as isocratic mobile phase, pumped at 1.0 mL min1 through
a cyano column (5 lm particle size). The analytes were detected at 215 nm. Statistical experimental
designs and graphic representations (response surface methodologies, Pareto charts) were used for
selecting the proper detection wavelength, optimizing the mobile phase composition, and assessing
method robustness.
The linearity of the calibration (r>0.99, n¼21) in the relevant ranges (up to 130% of the
expected concentrations of the analytes in the formulations), method accuracy (bias<2.0%),
repeatability (RSD<2.0%) and intermediate precision, were verified. In addition, specificity (peak
purities with photodiode array detector >0.9997) and method robustness were evaluated, and
system suitability parameters were determined.
The validated method was successfully employed for the routine analysis of various commercial
tablet and syrup pharmaceutical preparations against the common cold, showing satisfactory
analyte recoveries and RSD values.