A Multivariate Control Chart Approach for Calibration Transfer between NIR Spectrometers for Simultaneous Determination of Rifampicin and Isoniazid in Pharmaceutical Formulation.

Background: Multivariate transfer techniques have become a widely accepted concept over the past few years, since they avoid full recalibration procedures when instruments are changed to analyze a specific sample.

Objective: This paper reports a multivariate control chart transfer approach between two near infrared (NIR) spectrometers for simultaneous determination of rifampicin and isoniazid in pharmaceutical formu-lation using Direct Standardization (DS).

Method: The control charts are based on the calculation of Net Analyte Signal (NAS) models and the transfer samples are selected by the Kennard-Stone (KS) algorithm. Three control charts (NAS, interfer-ence and residual) transferred on both the master and slave instruments were measured.

Results: As a result, a classification model for rifampicin and isoniazid developed on a primary instrument has been successfully transferred to a secondary instrument. The spectral differences after the standardiza-tion procedure were considerably reduced and errors values found in the charts for both analytes were comparable with the errors obtained for the original chart models.

Conclusion: The proposed approach appears to be a valid alternative to the commonly used transfer of multivariate calibration models in simultaneous determination of isoniazid and rifampicin in pharmaceuti-cal formulation.