title: Application of HPLC mixed-mode chromatography in determining radiochemical purity of [(14) C] labeled metformin hydrochloride.
abstract: Metformin is currently prescribed worldwide to treat type 2 diabetes, and therefore, radiolabeled [(14) C] metformin is often prepared for clinical comparisons of new drug candidates. Prior to using the radiolabeled metformin, the purity needs to be determined to ensure the quality of the material. While typical reversed-phase LC methods are often the first choice for purity analysis, they are not suitable for this determination because the compound is poorly retained under these conditions. Mixed-mode chromatography has been demonstrated to overcome these retention issues, and therefore, this methodology was utilized for the purity determination of radiolabeled metformin.
authors.affiliation: Analytical and Process Chemistry, Merck Research Laboratories, Rahway, NJ, 07065, USA.
authors.forename: Van
authors.initials: V
authors.lastname: Truong
authors.forename: Roy
authors.initials: R
authors.lastname: Helmy
authors.forename: Sumei
authors.initials: S
authors.lastname: Ren
authors.forename: David
authors.initials: D
authors.lastname: Schenk
authors.forename: David
authors.initials: D
authors.lastname: Waterhouse
mesh_terms: D002250:Carbon Radioisotopes / Q000032:analysis / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D007553:Isotope Labeling / Q000379:methods*; D008422:Materials Testing / Q000379:methods; D008687:Metformin / Q000032:analysis / Q000737:chemistry*; D019275:Radiopharmaceuticals / Q000032:analysis* / Q000138:chemical synthesis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D002250:Carbon Radioisotopes; D019275:Radiopharmaceuticals; D008687:Metformin
keywords: [14C] labeled metformin hydrochloride; mixed-mode chromatography; radiochemical purity