Quantification of the enantiomeric excess of two APIs by means of near infrared spectroscopy and chemometrics

A method for the quantification of the enantiomeric excess of two pharmaceutical active ingredients (ibuprofen and epinephrine) in the solid state based on coupling near infrared spectroscopy and chemometrics is proposed. In the case of ibuprofen, in the absence of excipients, the method resulted in an accurate prediction of the enantiopurity of the validation samples (RMSEP < 2.0% and practically no bias). On the other hand, the use of “matrix-matched” standards, including the most commonly used excipients, allowed to extend the applicability of the approach also to the analysis of commercial drugs (RMSEP = 7.0%). As far as epinephrine is concerned, very accurate results were obtained (RMSEP < 2% and bias = 0.5%).