Development and Validation of an HPLC Method for the Simultaneous Determination of Bromhexine, Chlorpheniramine, Paracetamol and Pseudoephedrine in their Combined Cold Medicine Formulations

VIGNADUZZO, S. E.; KAUFMAN, T. S.

JOURNAL OF LIQUID CHROMATOGRAPHY AND RELATED TECHNOLOGIES

TAYLOR & FRANCIS INC

Lugar: Londres; Año: 2013 vol. 36 p. 2829 - 2843

1082-6076

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, n = 21) 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.