期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 70, 期 -, 页码 188-193出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2012.06.029
关键词
Nimodipine; Polymorphism; Differential scanning calorimetry; X-ray powder diffraction
资金
- National Council of Technological and Scientific Development (CNPq)
- Post Graduate Program in Pharmacy of the Federal University of Santa Catarina (UFSC)
Due to the physical-chemical and therapeutic impacts of polymorphism, its monitoring in raw materials is necessary. The purpose of this study was to develop and validate a quantitative method to determine the polymorphic content of nimodipine (NMP) raw materials based on differential scanning calorimetry (DSC). The polymorphs required for the development of the method were characterized through DSC, Xray powder diffraction (XRPD) and Raman spectroscopy and their polymorphic identity was confirmed. The developed method was found to be linear, robust, precise, accurate and specific. Three different samples obtained from distinct suppliers (NMP 1, NMP 2 and NMP 3) were firstly characterized through XRPD and DSC as polymorphic mixtures. The determination of their polymorphic identity revealed that all samples presented the Modification I (Mod I) or metastable form in greatest proportion. Since the commercial polymorph is Mod I, the polymorphic characteristic of the samples analyzed needs to be investigated. Thus, the proposed method provides a useful tool for the monitoring of the polymorphic content of NMP raw materials. (C) 2012 Elsevier B.V. All rights reserved.
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