The aim of this study was to quantitatively determine the olanzapine in a pharmaceutical formulation for assessing the potentiality of near infrared spectroscopy (NIR) combined with partial least squares (PLS) regression. The method was developed with samples based on a commercial formulation containing olanzapine and seven excipients. Laboratory and commercial samples (n = 27 and 18, respectively) were used by defining the calibration and prediction sets. The method was validated in the range from 1.0 to 12.5 of olanzapine per 100 mg of powder (average mass 210 mg), by accuracy, precision, linearity, analytical sensitivity, limit of detection and quantification. The multivariate model developed for olanzapine was based on PLS and the determination coefficient (rc and rp), with the root mean square error of calibration and prediction being 0.95, 0.93, 3.2 × 10-3 and 4.0 × 10-3% m/m, respectively. The proposed NIR method is an effective alternative for quantification of olanzapine in the pharmaceutical industry.
Keywords:
near infrared spectroscopy; olanzapine; partial least squares regression; figure of merit; HPLC
