Li Xiang-yang, Ding Li, Li Li-min, Hao Xin-yu, Zhang Zheng-xing
Department of Pharmacology, Qinghai Medical College, Xining 810001, China.
Yao Xue Xue Bao. 2003 Jun;38(6):455-7.
To develop an HPLC-MS assay for determination of finasteride in human plasma and to investigate the bioequivalence in healthy volunteers.
After alkalization with sodium hydroxide, plasma was extracted with ethyl acetate and separated using a C18 column with a mobile phase of methanol-water (85:15). LC-ESI-MS was performed in the selected ion monitoring (SIM) mode using target ions at m/z 395 for finasteride and m/z 407 for the IS. The fragmentor voltage was 120 V. A randomized crossover design was performed in 20 healthy volunteers. In the two study periods, a single 10 mg dose of each tablet was administered to each volunteer.
Calibration curves were linear over the range 1-200 micrograms.L-1 (r = 0.9986). The limit of determination for finasteride in plasma was 0.05 microgram.L-1. The recovery of finasteride from plasma was in the range of 85.9%-98.7%. The results of variance analysis and two one-side t-test showed that there was no significant difference between the two formulations in the AUC and Cmax.
The assay was proved to be sensitive, accurate and convenient. The two formulations were bioequivalent.
