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Development and Validation of RP-HPLC Method for Determination of Thermal Degradation Impurity in Macrolide Immunosuppressant Substance and Drug ProductBy Nisha Shri, J. Balaji
Abstract: The present study describes a simple and stability-indicating reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantification of the thermal degradation impurities of Tacrolimus (FK506) namely Ally ester rearrangement impurity (Impurity R) in Tacrolimus capsules and drug substances. Successful separation of impurity R from Tacrolimus, its other related substances and its tautomers were achieved on a Zorbax XDB C8 (150×4.6 mm, 5 μm) and detector of UV at 210 …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 1, 2016 · pp. 14–19 Read article →