Abstract
Near infrared spectroscopic and multivariate statistical control charts based on the net analyte signal (NAS) were applied to the polymorphic characterization of Piroxicam samples. Three different polymorphic forms (I, II and III) were studied, using X-ray powder diffraction (XRPD) and scanning electron microscopy as reference techniques. Samples containing form I were considered inside the quality specifications and forms II and III were impurities. Three control charts were developed: the NAS chart that corresponds to the analyte of interest (polymorphic form I), the interference chart that corresponds to the contribution of other compounds in the sample and the residual chart that corresponds to nonsystematic variation. From the limits estimated for each chart using samples inside the quality specifications, it was possible to identify samples that did not present polymorphic form I. The use of multivariate control charts provides a rapid evaluation of purity and the polymorphic composition of pharmaceutical formulations based on Piroxicam.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
