Abstract

MADRIGAL REDONDO, German Leonardo; VARGAS ZUNIGA, Rolando; CARAZO BERROCAL, Gustavo  and  RAMIREZ ARGUEDAS, Nils. Identification of two polymorphic forms of clopidogrel bisulphate crystal in pharmaceutical raw materials. Rev Cubana Farm [online]. 2014, vol.48, n.2, pp. 168-183. ISSN 0034-7515.

Introduction: clopidogrel bisulphate exists in many crystalline forms that vary in their physicochemical stability: some of these forms either patented or not are useful in the drug production. Objective: to identify the existing crystalline forms in two samples of Clopidogrel bisufhate raw material for the drug and the purity index of both samples. Methods: the raw material samples were taken from a domestic industry. They were tested through advanced analytical techniques such as differential scanning calorimetry, X-ray scattering pattern, infrared spectroscopy and thermogravimetric analysis. The final values were then compared with the well-established state-of-the-art values found in the reviewed literature for the clopidrogrel bisulfate raw materials and accepted as reference. Results: the physicochemical parameters were obtained from the absorption spectra, thermograms and diffractograms. The TA Universal Analysis software yielded the percentage of decomposition, the melting points and the peak identifiers in the samples. Conclusions: its was concluded that the sample 1 contained the crystal form I of the Clopridogrel bisulfate that is not a pure one since there is a characteristic band indicating contamination with the crystalline form II. The sample 2 had the pure crystalline form II of the product

Keywords : differential scanning calorimetry; Clopidogrel bisulfate; X-ray scattering pattern; infrared spectroscopy; pharmaceutical polymorphism; thermogravimetry.

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