Ronsen Research LLC

Chicago, IL, United States

Ronsen Research LLC

Chicago, IL, United States
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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 [2013]. Published by Oxford University Press. All rights reserved.


PubMed | Ronsen Research LLC
Type: Journal Article | Journal: 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--hydroxy vitamin D2 (Doxercalciferol related degradation product/Impurity B) as standard and 1--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.

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