Analysing the crystal purity of mebendazole raw material and its stability in a suspension formulation

Agatonovic-Kustrin , S., Glass, B.D., Mangan, M., and Smithson, J. (2008) Analysing the crystal purity of mebendazole raw material and its stability in a suspension formulation. International Journal of Pharmaceutics, 361 (1-2). pp. 245-250.

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Abstract

The objective of this study was to develop a simple, direct and non-destructive method to assess crystal purity of mebendazole raw material and to establish its stability in a suspension formulation using diffuse reflectance ultraviolet (DRA-UV) spectroscopy and attenuated total reflectance-Fourier transform infrared (ATR-FTIR) spectroscopy. Quantitation of mebendazole, found to exhibit polymorphism with three polymorphic forms A, B and C identified, was carried out with ATR-FTIR spectroscopy. Artificial neural network (ANN) was employed as a data-modelling tool. The developed ANN models confirmed that the characteristic absorptions in the infrared (IR) spectral region are directly proportional to the measured amounts of mebendazole crystal forms present in the samples (r2 > 0.94), which was confirmed with X-ray diffraction (XRD) at r2 > 0.97. These models also predicted that the mebendazole raw material contained 7.21 ± 1.25% (ATR-FTIR data) and 10.38 ± 0.18% (XRD data) of form A as an impurity. ATR-FTIR data for the suspension formulation showed some dissolution of form C and recrystalisation as the more stable form A. These quantitative results obtained for the binary crystal form mixtures clearly demonstrate the strong potential of ATR-FTIR for use in the determination of the polymorphic content not only in bulk pharmaceuticals but also in liquid formulations.

Item ID: 6469
Item Type: Article (Refereed Research - C1)
Keywords: mebendazole suspension; mebendazole crystal purity; artificial neural network; polymorphic meixtures; diffuse reflectance UV spectroscopy; ATR-FITR
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ISSN: 1873-3476
Date Deposited: 02 Mar 2010 04:28
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1199 Other Medical and Health Sciences > 119999 Medical and Health Sciences not elsewhere classified @ 100%
SEO Codes: 92 HEALTH > 9299 Other Health > 929999 Health not elsewhere classified @ 100%
Citation Count from Web of Science Web of Science 14
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