Jamrógiewicz Marzena, Ciesielski Aleksander
Department of Physical Chemistry, Faculty of Pharmacy with the Subfaculty of Laboratory Medicine, Medical University of Gdansk, Al. Gen. Hallera 107, 80-416 Gdańsk, Poland.
Quality Control Department, "Polpharma" Pharmaceutical Works, Pelplińska 19, 83-200 Starogard Gdański, Poland.
J Pharm Biomed Anal. 2015 Mar 25;107:236-43. doi: 10.1016/j.jpba.2015.01.012. Epub 2015 Jan 13.
This paper reports the study on applicability of Fourier transform infrared (FTIR), near-infrared (NIR) and Raman spectroscopy, differential scanning calorimetry (DSC) and X-ray diffraction (XRD) for the estimation of the chemical stability and photostability of histamine H2-receptor antagonist substances. Ranitidine hydrochloride (RAN), famotidine (FAM) and cimetidine (CIM) were tested and differences in sensitivity were measured via soft independence modeling of class analogies (Simca) model. The low values of variations for FAM and CIM and high variations obtained for RAN using FTIR and NIR techniques indicated that these methods were suitable and applicable to classify the degradation of RAN. Examined methods are recommendable in the first technological stage of drug production, and the preclinical and clinical development of pharmaceuticals or their quality control.
本文报道了傅里叶变换红外光谱（FTIR）、近红外光谱（NIR）、拉曼光谱、差示扫描量热法（DSC）和X射线衍射（XRD）在评估组胺H2受体拮抗剂物质化学稳定性和光稳定性方面的适用性研究。对盐酸雷尼替丁（RAN）、法莫替丁（FAM）和西咪替丁（CIM）进行了测试，并通过类类比软独立建模（Simca）模型测量了灵敏度差异。使用FTIR和NIR技术时，FAM和CIM的变化值较低，而RAN的变化值较高，这表明这些方法适用于对RAN的降解进行分类。所研究的方法在药物生产的第一个技术阶段、药物的临床前和临床开发或其质量控制中是值得推荐的。
