Related Experiment Video
Updated: Oct 9, 2026

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
Development and validation of a stability indicating HPLC assay method for cyclosporine in cyclosporine oral solution
M Kumar1, S K Singhal, A Singh
1Analytical Research&Development, Panacea Biotec Ltd., Chandigarh Road, PO Lalru (140 501), Punjab, India.
Abstract:
The suitability of the United States Pharmacopeia (USP) assay method for analysing stressed samples of cyclosporine oral solution USP was evaluated for stability samples by analyzing cyclosporine oral solution after acid, alkali, hydrogen peroxide, heat and light treatment. Some of the degradants generated during stress testing, as well as dihydrocyclosporine A, which is a known degradant of cyclosporine A, were not adequately resolved from the cyclosporine peak and mobile phase adjustments did not improve the resolution. In addition, isocyclosporine A, another known degradant of cyclosporine, could not be quantitated as it was eluting too early with the system peaks. Therefore, a binary gradient, reverse phase, stability indicating, HPLC method for the assay of cyclosporine in cyclosporine oral solution USP has been developed and validated. Analysis of degraded samples showed that the cyclosporine A eluted as a spectrally pure peak resolved from its degradation products.
Related Concept Videos
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Clinically Relevant Drug Product Specifications: Methods of Establishment
In Vitro Drug Dissolution: Compendial Testing Models II
Drug Product Stability
Dosage Interval and Administration Route: Determination Methods
