The Use of Near Infrared Spectroscopy and Multivariate Calibration for Determining the Active Principle of Olanzapine in a Pharmaceutical Formulation

Abstract

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 (r c and r p ), 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 IntroductionAtypical antipsychotics are a group of antipsychotic drugs used to treat psychiatric conditions. Some atypical antipsychotics 1 have received regulatory approval for schizophrenia, bipolar disorder, autism, and as an adjunct in major depressive disorder. The first-line psychiatric treatment for schizophrenia and bipolar disorder is antipsychotic medication which includes olanzapine.2 Olanzapine (Figure 1) is a synthetic derivative of thienobenzodiazepine with antipsychotic, antinausea and antiemetic activities. 3 Several analytical methods have been described for the quantification of olanzapine in biological fluids, pharmaceutical formulations and tissues such as high performance liquid chromatography (HPLC) with ultraviolet 4,5 or electrochemical detection, 6 liquid chromatography/electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) 7 and mass spectrometry imaging (MSI) using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS).8 Although these cited analytical methods indicate the effectiveness of liquid chromatography owing to its reliability, accuracy, reproducibility of results and sensitive analytical method for the determination of olanzapine in various studies, they are time consuming and require experienced personnel to perform the analysis. Furthermore, they are also destructive methods involving sample preparations. For all of these reasons, the search for new analytical techniques is of fundamental importance, especially those which lower both analysis time and cost. On the other hand, near infrared spectroscopy (NIRS) has been developed and proven to be a powerful tool for the pharmaceutical industry due to some characteristics such as being a fast and non-destructive 24 have also adopted guidelines for validating methodology which employs NIR spectroscopy using established chemometrics tools, and evaluating parameters ...

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