Development and metrological characterization of quantitative X-ray diffraction phase analysis for the mixtures of clopidogrel bisulphate polymorphs

Journal of Pharmaceutical and Biomedical Analysis
Vladimir Uvarov, Inna Popov

Abstract

Clopidogrel bisulphate (CLP) is a pharmaceutical compound with a novel mechanism of action for the reduction of atherosclerotic events. Only two crystalline forms (CLP I and CLP II) among the six known polymorphs of CLP have therapeutic activity. The structure of the CLP I polymorph is unknown and the structure of the CLP II polymorph is known only partially. Two techniques of X-ray diffraction quantitative phase analysis have been developed in this work for the quantification of CLP I and CLP II in their mixtures. The first technique is based on use of the whole powder pattern decomposition method (WPDM). WPDM was realized through Powder Cell for Windows v.2.4 (PCW) freeware. The second technique is based on the classical direct method. Metrological characterization and comparison of methods have been performed on the mixtures with known phase composition as well as on the real samples with varying phase content. Quantitative phase analyses of 120 specimens containing mixtures of forms I and II of CLP were performed using both developed techniques. Absolute and relative errors and reproducibility of both methods were found to be very similar. The statistical analysis of obtained results revealed that the WPDM gives higher accu...Continue Reading

Citations

Nov 14, 2014·Journal of Pharmaceutical Sciences·Edyta PindelskaWaclaw Kolodziejski
Nov 7, 2009·Journal of Pharmaceutical Sciences·Harry G Brittain
Aug 30, 2011·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·K VeldreJ Jaunbergs
Jan 31, 2015·Journal of Pharmaceutical and Biomedical Analysis·Jing-bo QiuMu-rong Zhu
Jan 1, 2011·Annual Review of Chemical and Biomolecular Engineering·Alfred Y LeeAllan S Myerson
Jun 28, 2014·International Journal of Pharmaceutics·Kailas S Khomane, Arvind K Bansal
May 10, 2017·Analytical Chemistry·Azhad U ChowdhuryGarth J Simpson
Oct 22, 2009·Pharmaceutical Development and Technology·Shahnwaz AlamArvind Kumar Bansal
Jan 20, 2018·Critical Reviews in Analytical Chemistry·Kavitha JLakshmi K S

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