Aim To develop an
HPLC-MS assay for determination of
finasteride in human
plasma and to investigate the
bioequivalence in healthy volunteers. Methods After alkalization with sodium hydroxide, plasma was extracted with ethyl acetate and separated using a C 18 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. Results Calibration curves were linear over the
range 1-200 μg·L -1 (r= 0 998 6 ). The limit of determination for finasteride in plasma was 0 05 μg·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 C max . Conclusion The assay was proved to be sensitive, accurate and convenient. The two formulations were bioequivalent.
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