title: Application of vibrational spectroscopy, thermal analyses and X-ray diffraction in the rapid evaluation of the stability in solid-state of ranitidine, famotidine and cimetidine.
abstract: 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.
authors.affiliation: 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. Electronic address: majam@gumed.edu.pl.
authors.forename: Marzena
authors.initials: M
authors.lastname: Jamrógiewicz
authors.affiliation: Quality Control Department, "Polpharma" Pharmaceutical Works, Pelplińska 19, 83-200 Starogard Gdański, Poland.
authors.forename: Aleksander
authors.initials: A
authors.lastname: Ciesielski
mesh_terms: D002152:Calorimetry, Differential Scanning / Q000379:methods; D002927:Cimetidine / Q000737:chemistry*; D004355:Drug Stability; D015738:Famotidine / Q000737:chemistry*; D006635:Histamine H2 Antagonists / Q000737:chemistry; D011899:Ranitidine / Q000737:chemistry*; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods; D013059:Spectrum Analysis, Raman / Q000379:methods; D014732:Vibration; D014961:X-Ray Diffraction / Q000379:methods
chemical_list: D006635:Histamine H2 Antagonists; D015738:Famotidine; D002927:Cimetidine; D011899:Ranitidine
keywords: NIR; Photodegradation; Raman spectroscopy; Stability; XRD