Please use this identifier to cite or link to this item: https://doi.org/10.1016/j.ijpharm.2011.05.058
Title: Quantification of polymorphic impurity in an enantiotropic polymorph system using differential scanning calorimetry, X-ray powder diffraction and Raman spectroscopy
Authors: Li, Y.
Chow, P.S.
Tan, R.B.H. 
Keywords: DSC
Polymorphic impurity
PXRD
Quantification
Raman
Sulfamerazine
Issue Date: 30-Aug-2011
Source: Li, Y., Chow, P.S., Tan, R.B.H. (2011-08-30). Quantification of polymorphic impurity in an enantiotropic polymorph system using differential scanning calorimetry, X-ray powder diffraction and Raman spectroscopy. International Journal of Pharmaceutics 415 (1-2) : 110-118. ScholarBank@NUS Repository. https://doi.org/10.1016/j.ijpharm.2011.05.058
Abstract: The ability to detect and quantify polymorphism of pharmaceuticals is critically important in ensuring that the formulated product delivers the desired therapeutic properties because different polymorphic forms of a drug exhibit different solubilities, stabilities and bioavailabilities. The purpose of this study is to develop an effective method for quantitative analysis of a small amount of one polymorph within a binary polymorphic mixture. Sulfamerazine (SMZ), an antibacterial drug, was chosen as the model compound. The effectiveness and accuracy of powder X-ray diffraction (PXRD), Raman microscopy and differential scanning calorimetry (DSC) for the quantification of SMZ polymorphs were studied and compared. Low heating rate in DSC allowed complete transformation from Form I to Form II to take place, resulting in a highly linear calibration curve. Our results showed that DSC and PXRD are capable in providing accurate measurement of polymorphic content in the SMZ binary mixtures while Raman is the least accurate technique for the system studied. DSC provides a rapid and accurate method for offline quantification of SMZ polymorphs, and PXRD provides a non-destructive, non-contact analysis. © 2011 Elsevier B.V. All rights reserved.
Source Title: International Journal of Pharmaceutics
URI: http://scholarbank.nus.edu.sg/handle/10635/64481
ISSN: 03785173
DOI: 10.1016/j.ijpharm.2011.05.058
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