title: Quantitative determinations using portable Raman spectroscopy.
abstract: A portable Raman spectrometer was used to develop chemometric models to determine percent (%) drug release and potency for 500mg ciprofloxacin HCl tablets. Parallel dissolution and chromatographic experiments were conducted alongside Raman experiments to assess and compare the performance and capabilities of portable Raman instruments in determining critical drug attributes. All batches tested passed the 30min dissolution specification and the Raman model for drug release was able to essentially reproduce the dissolution profiles obtained by ultraviolet spectroscopy at 276nm for all five batches of the 500mg ciprofloxacin tablets. The five batches of 500mg ciprofloxacin tablets also passed the potency (assay) specification and the % label claim for the entire set of tablets run were nearly identical, 99.4±5.1 for the portable Raman method and 99.2±1.2 for the chromatographic method. The results indicate that portable Raman spectrometers can be used to perform quantitative analysis of critical product attributes of finished drug products. The findings of this study indicate that portable Raman may have applications in the areas of process analytical technology and rapid pharmaceutical surveillance.
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., Saint Louis, MO, 63110, United States.
authors.forename: Chelliah V
authors.initials: CV
authors.lastname: Navin
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., Saint Louis, MO, 63110, United States.
authors.forename: Chaitanya
authors.initials: C
authors.lastname: Tondepu
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., Saint Louis, MO, 63110, United States.
authors.forename: Roxana
authors.initials: R
authors.lastname: Toth
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., Saint Louis, MO, 63110, United States.
authors.forename: Latevi S
authors.initials: LS
authors.lastname: Lawson
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., Saint Louis, MO, 63110, United States. Electronic address: Jason.Rodriguez@fda.hhs.gov.
authors.forename: Jason D
authors.initials: JD
authors.lastname: Rodriguez
mesh_terms: D000900:Anti-Bacterial Agents / Q000032:analysis* / Q000737:chemistry; D002138:Calibration; D002939:Ciprofloxacin / Q000032:analysis* / Q000737:chemistry; D065546:Drug Liberation; D012995:Solubility; D013059:Spectrum Analysis, Raman / Q000379:methods*; D013607:Tablets
chemical_list: D000900:Anti-Bacterial Agents; D013607:Tablets; D002939:Ciprofloxacin