Development and Validation of RP-HPLC Method for Determination of Thermal Degradation Impurity in Macrolide Immunosuppressant Substance and Drug Product
Abstract
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 nm, 2.0 ml/min as a flow rate, and 20 μl as an injection volume. For the RP- HPLC method, 0.1% Trifluroacetic acid in water and Acetonitrile was used as a binary linear gradient and the column temperature was 55° C. Percentage recovery obtained in the range of 96.8%–101.2% and the method is linear for impurity R for specified concentration range with coefficient of variation (r) not less than 0.99. acid, base, oxidation, thermal and photolytic degradation have been carried in drug substance and drug product. The proposed RP-HPLC method was found to be specific, linear, precise, accurate and robust.
Keywords: Tacrolimus, FK506, Thermal degradation impurity, Allyl ester rearrangement impurity, RP-HPLC
Cite this Article
J. Balaji, C. Nisha Shri. Development and Validation of RP-HPLC Method for Determination of Thermal Degradation Impurity in Tacrolimus Drug Substance and Drug Product. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(1): 14–19p.
Downloads
Published
Issue
Section
License
Copyright Transfer and Declaration Form (Please compile this form, sign and send by e-mail and post)
Journal Title:
Title of the Paper:
Corresponding Author’s Information: Name: Address:
E-mail:
Contact Number: I
t is herein agreed that: The copyright to the above-listed unpublished and original article is transferred to STM Journals. This copyright transfer covers the exclusive right to reproduce and distribute the contribution, including reprints, translations, photographic reproductions, microform, electronic form (offline, online), or any other reproductions of similar nature. I/We declare that above manuscript is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere. I/ We warrant(s) that his/her/their contribution is original, except for such excerpts from copyrighted works as may be included with the permission of the copyright holder and author thereof, that it contains no libelous statements, and does not infringe on any copyright, trademark, patent, statutory right, or propriety right of others. I/We will not publish his/her/their above said contribution anywhere else without the prior written permission of the publisher unless it has been changed substantially.I/We also agree to the authorship of the article in the following order:Author(s) Name Signature(s)
1. ________________
2. _______________
_3. ________________
4. ________________
The author(s) agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal (comments if any to the editor can be added below).
