CALIBRATION LINE ADJUSTMENT TO FACILITATE THE USE OF SYNTHETIC CALIBRATION SAMPLES IN NEAR-INFRARED SPECTROMETRIC ANALYSIS OF PHARMACEUTICAL PRODUCTION SAMPLES

A method is proposed to build a reliable and stable model for the quan titative determination of pharmaceutical tablets, where the active ing redient concentration of production batches does not vary enough to en sure a stable calibration model. Therefore, some synthetic tablets bas ed on the same formula, but with an extended concentration range of th e active ingredient, are produced and used to build a calibration mode l. This model is then adjusted by the use of production samples. The m odel used is based on multiple linear regression and feature selection . Validation by predicting new independent production samples shows th at this procedure can be used for a satisfactory determination of the active ingredient.