title: Determination of degradation products of doxercalciferol by solid-phase extraction and reversed-phase HPLC.
abstract: In the current study, injectable formulations containing Doxercalciferol as the active pharmaceutical ingredient are analyzed by using gradient-elution high-performance liquid chromatography with ultraviolet detection. Various related impurities and degradants are quantified by using solid-phase extraction (SPE) for enhanced sensitivity. The assay of possible related impurities and Doxercalciferol analogues present at trace quantities is performed by using Trans-1-α-hydroxy vitamin D2 (Doxercalciferol related degradation product/Impurity B) as standard and 1-β-hydroxy vitamin D2 (Doxercalciferol related degradation product/Impurity C) as internal standards for the SPE study. The current method is shown to be stability-indicating and free from interferences from any of the formulation excipients and potential degradation products and impurities. The validated method is shown to be reproducible, accurate, sensitive and selective.
authors.affiliation: Ronsen Research, LLC, 2201 W. Campbell Park Drive, Chicago, IL 60612 ninussimonzadeh@aol.com.
authors.forename: Ninus
authors.initials: N
authors.lastname: Simonzadeh
authors.affiliation: Ronsen Research, LLC, 2201 W. Campbell Park Drive, Chicago, IL 60612.
authors.forename: Bruce
authors.initials: B
authors.lastname: Ronsen
authors.affiliation: Ronsen Research, LLC, 2201 W. Campbell Park Drive, Chicago, IL 60612.
authors.forename: Subhash
authors.initials: S
authors.lastname: Upadhyaya
authors.affiliation: Ronsen Research, LLC, 2201 W. Campbell Park Drive, Chicago, IL 60612.
authors.forename: Erik
authors.initials: E
authors.lastname: Wilkinson
authors.affiliation: Ronsen Research, LLC, 2201 W. Campbell Park Drive, Chicago, IL 60612.
authors.forename: Kiran
authors.initials: K
authors.lastname: Kanesvaran
authors.affiliation: Ronsen Research, LLC, 2201 W. Campbell Park Drive, Chicago, IL 60612.
authors.forename: Vijay
authors.initials: V
authors.lastname: Patel
authors.affiliation: Ronsen Research, LLC, 2201 W. Campbell Park Drive, Chicago, IL 60612.
authors.forename: Pravin
authors.initials: P
authors.lastname: Bendale
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004872:Ergocalciferols / Q000032:analysis* / Q000737:chemistry*; D015203:Reproducibility of Results; D052616:Solid Phase Extraction / Q000379:methods*
chemical_list: D004872:Ergocalciferols; C042533:1 alpha-hydroxyergocalciferol