Development and validation of smart spectrophotometric-chemometric methods for the simultaneous determination of chlorpheniramine maleate and etilefrine hydrochloride in bulk powder and in dosage form combinations

Abstract

This paper describes threesensitive, accurate and precise chemometricspectrophotometricmethods for the simultaneous determination of chlorpheniramine maleate (CPM) and etilefrine hydrochloride (ETF)in bulk powder and capsules without prior separation. Multivariate calibration chemometric methods are proposed for simultaneous determination of CPMandETF. The chemometric methods applied are classical least squares (CLS),principal component regression (PCR) and partial least squares (PLS). These approaches aresuccessfully applied to quantify both drugs using the information included in the absorption spectra of appropriate solutions.In these multivariatemethods, calibration sets of standard samples composed of different mixtures of CPMand ETFhave been designed. The methods were validated according to the International Conference on Harmonization (ICH) guidelines. The specificity of the proposed methods was tested using laboratory-prepared mixtures. The developed methods were successfully applied for the determination of CPM and ETF in bulk powder and dosage form combination.