In the present study, two different chemometric methods – partial least squares (PLS) and principal component regression (PCR) for simultaneous determination of montelukast sodium and fexofenadine hydrochloride in pharmaceuticals are described. These two approaches were successfully applied to resolve the overlapped data and quantify the two components in the studied mixture using the calibrations constructed with the absorption data matrix corresponding to the concentration data matrix with measurements in the range of 240-400 nm (Δλ = 1 nm) of the zero order spectra. The calibration range was found to be 5-25 µg mL-1 for montelukast sodium and 60-300 µg mL-1 for fexofenadine hydrochloride, respectively. The PLS and PCR methods neither require any separation step, nor any prior graphical treatment of the overlapping spectra of the two drugs in a mixture. The calibration of the chemometric models were evaluated by internal validation (prediction of components in its own designed training set of calibration) and by external validation over synthetic and pharmaceutical preparations. Both studied methods can be considered acceptable for the pharmaceutical quality assurance of montelukast sodium and fexofenadine hydrochloride in combined dosage forms.
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