title: Optimization and validation of a dissolution test for famotidine tablets using flow injection analysis.
abstract: A dissolution test for famotidine tablets was optimized and validated using flow injection analysis (FIA). The effect of dissolution parameters such as pH, medium and stirring speed was studied, while the ruggedness of the procedure was validated. All measurements were performed using a simple direct spectrophotometric flow injection assay (lambdamax=265 nm) that has also been optimized and fully validated in terms of linearity, limit of detection, precision, selectivity and accuracy. Linearity was obeyed in the range 50-150% of famotidine (20-60 mg L-1), while the detection limit (0.1 mg L-1) and repeatability (sr<1.0%, n=12) were satisfactory. The sampling rate was 30 h-1. The dissolution results during quality and stability control of two batches of famotidine tablets obtained by the flow injection method were in good agreement with high-performance liquid chromatography (HPLC).
authors.affiliation: Quality Control Department, Cosmopharm Ltd., P.O. Box 42, Korinthos 20100, Greece. paristzanavaras@gmail.com
authors.forename: Paraskevas D
authors.initials: PD
authors.lastname: Tzanavaras
authors.forename: Aspasia
authors.initials: A
authors.lastname: Verdoukas
authors.forename: Theodora
authors.initials: T
authors.lastname: Balloma
mesh_terms: D000897:Anti-Ulcer Agents / Q000737:chemistry*; D004355:Drug Stability; D015738:Famotidine / Q000737:chemistry*; D017022:Flow Injection Analysis / Q000379:methods*; D006635:Histamine H2 Antagonists / Q000737:chemistry*; D011786:Quality Control; D015203:Reproducibility of Results; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D013678:Technology, Pharmaceutical; D013997:Time Factors
chemical_list: D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D013607:Tablets; D015738:Famotidine