Aim: ZY-19489 is a new antimalarial drug candidate and selective LC–MS/MS method was established for estimation of ZY-19489 and its metabolite in human plasma. Materials & methods: LLE was employed for extraction, mass spectrometric quantification performed using positive ionization mode and DCP-IMP was used as an internal standard. The chromatographic separation was achieved using mobile phase 5 mM ammonium formate in water and 0.1% v/v ammonia solution in methanol:acetonitrile (90:10% v/v) and column Agilent Zorbex Extended C18, 3.5 μm, 100 × 4.6 mm with a 6-min run time. Results: The calibration curve of ZY-19489 was linear over range 1–500 ng/ml and 2–200 ng/ml for metabolite. Assay was reproducible, selective and devoid of matrix effect. Conclusion: The validated assay was implemented for clinical sample analysis derived from healthy human subjects and parasitemia-induced subjects.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 13, No. 23

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History

Received 8 September 2021

Accepted 18 October 2021

Published online 15 November 2021

Published in print December 2021

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Financial & competing interest disclosure

This study was funded by Cadila Healthcare Limited, based at Ahmedabad, Gujarat, India. The clinical phase of study (ACTRN12619000127101) was performed at Q-Pharm, Australia and Bioanalytical phase of the study was conducted at Bioanalytical Laboratory, Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India. Zydus Research Centre (ZRC) communication number: 668. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of the research

Authors used thoroughly validated bioanalytical method for evaluation of human plasma samples for PK evaluation in first in human study. The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

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