Bioequivalence Study of Finasteride Tablets in Human Plasma by HPLC-MS

January 2012 in “ Pharmacy Today ”

Bingren Xiang

finasteride bioequivalence HPLC-MS plasma C18 column methanol-NH4 Acsolution Cmax AUC0-t-test Tmax Propecia

TLDR The test and reference finasteride tablets are bioequivalent.

The study established a new RP-HPLC-MS method to determine finasteride concentration in plasma and assess its bioequivalence. Using a C18 column and a methanol-NH4 Acsolution mobile phase, the method demonstrated linearity in the range of 0.5-200 ng/ml, with a precision RSD of 10.0% and an absolute recovery of 84.71%-89.05%. The study involved 20 healthy volunteers and concluded that the test and reference finasteride tablets were bioequivalent based on Cmax, AUC0-t-test, and Tmax data.

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