Transfer of NIR calibrations for pharmaceutical formulations between different instruments.
In order to evaluate how well existing techniques for transferring NIR calibrations perform for solid pharmaceutical formulations, a study on four assays of active ingredients was undertaken. The study included two configurations of dispersive NIR instruments and one Fourier transform (FT) instrument. Three methods for calibration transfer: slope/bias correction, local centring and piecewise direct standardisation (PDS), were tested and evaluated. Our conclusions are that the calibration transfer methods tested can perform equally well. It was shown that it is possible to transfer calibrations between instruments of different configurations or even of different types, without loosing the prediction ability of the calibration. To achieve a good calibration transfer, a larger variation in the content of the active ingredient in the samples and more samples are needed for the slope and bias correction method compared to the local centring method. For PDS to be a successful calibration transfer method, an optimisation of the number of transfer samples and how they are selected together with various factors specific for this method is needed. Local centring is the preferred transfer method as its performance is excellent yet it is simple to perform, no optimisation is needed, only a few transfer samples are required and the transfer samples do not have to vary in their content of the active ingredient.
Bergman
Eva-Lotta
EL
AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden. eva-lotta.bergman@astrazeneca.com
Brage
Henric
H
Josefson
Mats
M
Svensson
Olof
O
Sparén
Anders
A
D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D005583:Fourier Analysis; D004364:Pharmaceutical Preparations / Q000032:analysis; D012015:Reference Standards; D015203:Reproducibility of Results; D017550:Spectroscopy, Fourier Transform Infrared / Q000295:instrumentation* / Q000379:methods*; D019265:Spectroscopy, Near-Infrared / Q000295:instrumentation* / Q000379:methods*; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*
D004364:Pharmaceutical Preparations; D013607:Tablets