Validated LC–MS/MS Method For The Determination Of Copanlisib In Mouse Dried Blood Spots

By Harsha K. Tripathy, Karnataka College of Pharmacy, and Vinay Kiran, Ashok Zakkula, Vinod A. B., Rama Murthy Bestha, Sreekanth Dittakavi, and Ramesh Mullangi, Drug Metabolism and Pharmacokinetics, LAXAI

Copanlisib is a phosphatidylinositol 3-kinase inhibitor used in the treatment of relapse and refractory follicular lymphoma. Few bioanalytical methods have been published for analyzing copanlisib, which are either LC–MS/MS or HPLC based. This research examines the method development and validation of an LC–MS/MS method for the quantitation of copanlisib in mouse blood using dried blood spot (DBS) cards without compromising on the sensitivity.

DBS technique has emerged as a viable alternative to bioanalytical method in both preclinical and clinical studies. The lower blood volume requirement for analysis, simple and easy storage and transport of DBS discs, and increased stability of the drug in storage make it a more efficacious, risk-averse option over conventional matrices. The technique also requires small blood volumes (typically 10 μl), helping researchers to decrease the numbers of animals, especially rodents, used in exploratory pharmacokinetic and toxicokinetic studies.

Review the study’s findings on a validated LC–MS/MS method for quantifying copanlisib from a mouse DBS and its potential for enabling desirable sensitivity, accuracy, and precision.