Simonzadeh N.,Ronsen Research LLC |
Ronsen B.,Ronsen Research LLC |
Upadhyaya S.,Ronsen Research LLC |
Wilkinson E.,Ronsen Research LLC |
And 3 more authors.
Journal of Chromatographic Science | Year: 2014
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. © 2013 The Author . Published by Oxford University Press. All rights reserved.