title: A novel method for the determination of chemical purity and assay of menaquinone-7. Comparison with the methods from the official USP monograph.
abstract: An HPLC method with UV detection and separation with the use of a C30 reversed phase analytical column for the determination of chemical purity and assay of menaquinone-7 (MK7) in one chromatographic run was developed. The method is superior to the methods published in the USP Monograph in terms of selectivity, sensitivity and accuracy, as well as time, solvent and sample consumption. The developed methodology was applied to MK7 samples of active pharmaceutical ingredient (API) purity, MK7 samples of lower quality and crude MK7 samples before purification. The comparison of the results revealed that the use of USP methodology could lead to serious overestimation (up to a few percent) of both purity and MK7 assay in menaquinone-7 samples.
authors.affiliation: Pharmaceutical Research Institute, R&D Analytical Chemistry Department, Rydygiera 8, 01-793 Warsaw, Poland. Electronic address: l.jedynak@ifarm.eu.
authors.forename: Łukasz
authors.initials: Ł
authors.lastname: Jedynak
authors.affiliation: Pharmaceutical Research Institute, R&D Analytical Chemistry Department, Rydygiera 8, 01-793 Warsaw, Poland.
authors.forename: Maria
authors.initials: M
authors.lastname: Jedynak
authors.affiliation: Pharmaceutical Research Institute, R&D Analytical Chemistry Department, Rydygiera 8, 01-793 Warsaw, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Kossykowska
authors.affiliation: Pharmaceutical Research Institute, R&D Analytical Chemistry Department, Rydygiera 8, 01-793 Warsaw, Poland.
authors.forename: Joanna
authors.initials: J
authors.lastname: Zagrodzka
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004340:Drug Contamination; D010602:Pharmacopoeias as Topic / Q000592:standards; D010782:Photolysis; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D014481:United States; D024482:Vitamin K 2 / Q000031:analogs & derivatives* / Q000032:analysis / Q000378:metabolism
chemical_list: D024482:Vitamin K 2; C062629:menaquinone 7
keywords: Assay; Chemical purity; Degradation studies; HPLC; Menaquinone-7