title: A validated ultra high pressure liquid chromatographic method for qualification and quantification of folic acid in pharmaceutical preparations.
abstract: A fully validated UHPLC method for the identification and quantification of folic acid in pharmaceutical preparations was developed. The starting conditions for the development were calculated starting from the HPLC conditions of a validated method. These start conditions were tested on four different UHPLC columns: Grace Vision HT™ C18-P, C18, C18-HL and C18-B (2 mm × 100 mm, 1.5 μm). After selection of the stationary phase, the method was further optimised by testing two aqueous and two organic phases and by adapting to a gradient method. The obtained method was fully validated based on its measurement uncertainty (accuracy profile) and robustness tests. A UHPLC method was obtained for the identification and quantification of folic acid in pharmaceutical preparations, which will cut analysis times and solvent consumption.
authors.affiliation: Dept of Pharmaco-Bromatology, Section Medicinal Products, Scientific Institute of Public Health, J Wytmansstraat 14, 1050 Brussels, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Deconinck
authors.forename: S
authors.initials: S
authors.lastname: Crevits
authors.forename: P
authors.initials: P
authors.lastname: Baten
authors.forename: P
authors.initials: P
authors.lastname: Courselle
authors.forename: J
authors.initials: J
authors.lastname: De Beer
mesh_terms: D000704:Analysis of Variance; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D005492:Folic Acid / Q000302:isolation & purification*; D057230:Limit of Detection; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D012015:Reference Standards; D015203:Reproducibility of Results; D014815:Vitamins / Q000032:analysis* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations; D014815:Vitamins; D005492:Folic Acid