Quantitative analysis of polymorphic mixtures of ranitidine hydrochloride by raman spectroscopy and principal components analysis

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Ranitidine hydrochloride exists as two polymorphs, forms I and II, both of which are used to manufacture commercial tablets. Raman spectroscopy can be used to differentiate the two forms but univariate methods of quantitative analysis of one polymorph as an impurity in the other lack sensitivity. We have applied principal components analysis (PCA) of Raman spectra to binary mixtures of the two polymorphs and to binary mixtures prepared by adding one polymorph to powdered tablets of the other. Based on absorption measurements of seven spectral regions, it was found that >97% of the spectral variation was accounted for by three principal components. Quantitative calibration models generated by multiple linear regression predicted a detection limit and quantitation limit for either forms I or II in mixtures of the two of 0.6 and 1.8%, respectively. This study demonstrates that PCA of Raman spectroscopic data provides a sensitive method for the quantitative analysis of polymorphic impurities of drugs in commercial tablets with a quantitation limit of less than 2%.

Original languageEnglish
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Issue number3
Pages (from-to)337-341
Number of pages5
Publication statusPublished - Nov 2002

    Research areas

  • Polymorphism, Principal components analysis, Quantitative analysis, Raman spectroscopy, Ranitidine-HCl

ID: 299430095