title: Stability-Indicating HPLC-UV Method for Vitamin D3 Determination in Solutions, Nutritional Supplements and Pharmaceuticals.
abstract: A simple and fast high-performance liquid chromatography method with UV detection for determination of vitamin D3 in stability studies as well as in solutions, nutritional supplements and pharmaceuticals was developed. Successful separation of vitamin D3 from its degradation products was achieved on a Gemini C18 100 × 3.0 mm column using a mixture of acetonitrile and water (99:1, v/v) as а mobile phase. The method was successfully validated according to the ICH guidelines. The described reversed-phase HPLC method is favorable compared with other published HPLC-UV methods because of its stability-indicating nature, short run time (3.3 min) and wide analytical range with outstanding linearity, accuracy and precision. The method was further applied for quantification of vitamin D3 in selected liquid and solid nutritional supplements and prescription medicines, confirming its suitability for routine analysis. Degradation products, formed under stress conditions (hydrolysis, oxidation, photolysis and thermal degradation), were additionally elucidated by suitable equipment (LC-DAD-MS) to confirm the stability-indicating nature of the developed method.
authors.affiliation: Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, Ljubljana 1000, Slovenia.
authors.forename: Žane
authors.initials: Ž
authors.lastname: Temova
authors.affiliation: Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, Ljubljana 1000, Slovenia robert.roskar@ffa.uni-lj.si.
authors.forename: Robert
authors.initials: R
authors.lastname: Roškar
mesh_terms: D000097:Acetonitriles; D002762:Cholecalciferol / Q000737:chemistry / Q000302:isolation & purification*; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards*; D056148:Chromatography, Reverse-Phase / Q000379:methods / Q000592:standards*; D004355:Drug Stability; D006358:Hot Temperature; D006801:Humans; D006868:Hydrolysis; D057230:Limit of Detection; D010084:Oxidation-Reduction; D010782:Photolysis; D012997:Solvents; D013607:Tablets; D014867:Water
chemical_list: D000097:Acetonitriles; D012997:Solvents; D013607:Tablets; D014867:Water; D002762:Cholecalciferol; C032159:acetonitrile