ArticleDrug design, development and therapy2026
Development and Validation of an HPLC-MS/MS Method for Pharmacokinetic Evaluation of Tofacitinib/Simvastatin Compound Ointment in Rats.
Article in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Propose: Oxidative stress and immune dysfunction are closely associated with the onset and progression of vitiligo. Therefore, simultaneously regulating these two key pathological processes to achieve synergistic therapy is a practically feasible strategy. Based on this rationale, we previously developed a topical ointment co-loaded with antioxidant simvastatin and immunosuppressant tofacitinib, and evaluated its therapeutic potential for vitiligo. However, the lack of a bioanalytical method for simultaneous in vivo quantification of the two drugs has hindered further pharmacodynamic and pharmacokinetic studies of the formulation. The present study aimed to establish and validate an HPLC-MS/MS method for simultaneous determination of their in vivo concentrations, to support pharmacokinetic investigations of the ointment in rats. Methods : Chromatographic separation was performed on a ZORBAX Eclipse C Results: The results demonstrated that the method met all validation criteria and was suitable for pharmacokinetic studies. Pharmacokinetic data showed that, compared with oral gavage, the 24 h bioavailability of tofacitinib and simvastatin after topical administration was only 7.1% and 5.2%, respectively. This low systemic exposure indicated that the ointment formulation could effectively reduce the potential toxicity caused by excessive drug absorption into the circulation.
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