Analysis of the polymorphs of carbamazepin tablets by laser confocal micro-Raman spectrometer and establishment of the identification test model / 中国药学杂志

ABSTRACT

OBJECTIVE: To analyze the polymorphs of carbamazepin tablets by laser confocal micro-Raman spectrometer and establish the identification test model. METHODS: Reference Raman spectra of the four crystal forms of carbamazepin were established; then the polymorphs of the carbamazepin tablets from different manufacturers were analyzed, and an identification test model was established to distinguish the unknown samples. RESULTS: According to the results of the cluster analysis, the four batches of carbamazepin tablets from domestic manufacturers belonged to crystal form III. A qualitative model was created by choosing the first derivative and vector normalization method to process the spectra, using the factorization method to calculate, and selecting the 200-500, 650-850, 1 000-1 100, 1 500-1 700 cm-1 regions to compare. This model was verified to have high sensitivity, specificity, precisicion, negative prediction ability, and detection efficiency. CONCLUSION: The laser confocal micro-Raman spectrometer canbe used to analyze the polymorphs of carbamazepin tablets and the qualitative identification is rapid and accurate.