Over the last few years, studies on quantification and determination of various polymorph forms in complex matrices have become a key point in research by pharmaceutical industries. Studies on their quantification are also requested by the FDA, because the various polimorphs are characterized by a different bioavailability in the organism. For these reasons, the method consists in an X-ray diffractometric analysis combined with the partial least square. The analyzed drugs are the Budesonide (BDS), a glucocorticoid used for the treatment ofasthmatic pathologies and the Tachifludec, whose API is paracetamol, commonly used for inflammatory diseases. This work is done by preparing – through the method of standard addition – specimens that will be submitted to XRPD. The obtained diffractograms are then submitted to multivariate analysis through partial least square 1, by using the Unscrambler 10.4 software. The main advantage of chemometrics is its easy applicability. Moreover, thanks to the data obtained by the multivariate regression, it can be confirmed that the chosen method is extremely valid to solve these kinds of problem.
Quantification of polymorphs form in Pharmaceutical Compounds Based on Powder X-Ray Diffraction with partial least square
LOCATELLI, Marcello
2017-01-01
Abstract
Over the last few years, studies on quantification and determination of various polymorph forms in complex matrices have become a key point in research by pharmaceutical industries. Studies on their quantification are also requested by the FDA, because the various polimorphs are characterized by a different bioavailability in the organism. For these reasons, the method consists in an X-ray diffractometric analysis combined with the partial least square. The analyzed drugs are the Budesonide (BDS), a glucocorticoid used for the treatment ofasthmatic pathologies and the Tachifludec, whose API is paracetamol, commonly used for inflammatory diseases. This work is done by preparing – through the method of standard addition – specimens that will be submitted to XRPD. The obtained diffractograms are then submitted to multivariate analysis through partial least square 1, by using the Unscrambler 10.4 software. The main advantage of chemometrics is its easy applicability. Moreover, thanks to the data obtained by the multivariate regression, it can be confirmed that the chosen method is extremely valid to solve these kinds of problem.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
