title: Determination of polymorphic forms of ranitidine-HCl by DRIFTS and XRPD.
abstract: The identification, characterization and quantification of crystal forms are becoming increasingly important within the pharmaceutical industry. A combination of different physical analytical techniques is usually necessary for this task. In this work solid-state techniques, diffuse reflectance infrared Fourier transform spectroscopy (DRIFTS) and X-ray powder diffractometry (XRPD) were combined to analyze polymorphic purity of crystalline ranitidine-HCl, an antiulcer drug, H2 receptor antagonists. A series of 12 different mixtures of Form 1 and 2 was prepared by geometric mixing and their DRIFT spectra and XRD powder patterns were obtained and analyzed, either alone or combined together, using Artificial Neural Networks (ANNs). A standard feed-forward network, with back-propagation rule and with multi layer perceptron architecture (MPL) was chosen. A working range of 1.0-100% (w/w) of crystal Form 2 in Form 1 was established with a minimum quantifiable level (MQL) of 5.2% and limit of detection of 1.5% (w/w). The results demonstrate that DRIFTS combined with XRPD may be successfully used to distinguish between the ranitidine-HCl polymorphs and to quantify the composition of binary mixtures of the two.
authors.affiliation: School of Pharmaceutical Science, Universiti Sains Malaysia, 11800, Penang, Malaysia. nena@usm.my
authors.forename: S
authors.initials: S
authors.lastname: Agatonovic-Kustrin
authors.forename: T
authors.initials: T
authors.lastname: Rades
authors.forename: V
authors.initials: V
authors.lastname: Wu
authors.forename: D
authors.initials: D
authors.lastname: Saville
authors.forename: I G
authors.initials: IG
authors.lastname: Tucker
mesh_terms: D011899:Ranitidine / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods*; D014961:X-Ray Diffraction / Q000379:methods*
chemical_list: D011899:Ranitidine