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Determination of finasteride in human plasma and its pharmacokinetics and relative bioavailability by HPLC-electrospray mass spectrometry / 中国新药与临床杂志
Chinese Journal of New Drugs and Clinical Remedies ; (12): 537-541, 2006.
Article in Chinese | WPRIM | ID: wpr-408504
ABSTRACT

AIM:

A new HPLC-MS method was developed to determine finasteride in human plasma.

METHODS:

Two formulations of finasteride tablets were given to 20 healthy male volunteers according to a randomized 2-way cross-over design. The samples were extracted by ethyl acetate under basic conditions, then were separated by C18 column and determined by mass detector.

RESULTS:

The calibration curve of finasteride was linear and intra-day and inter-day RSD were less than 10 %. The pharmacokinetics parameters of the two formulations (4.5 ± 0.5) h for t1/2; (3.0 ± 0.7) and (2.8 ± 0.9) h for tmax, respectively. The results indicated that there was no significant difference on cmax, A UC0-24, t1/2 or tmax values between the two formulations. CONCLUTION The relative bioavailability of tablets I with respect to tablets Ⅱ is (99.3 ± 9.2) % by the A UC0-24 measurement, and bioe quivalence is observed between the two tablets.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial Language: Chinese Journal: Chinese Journal of New Drugs and Clinical Remedies Year: 2006 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial Language: Chinese Journal: Chinese Journal of New Drugs and Clinical Remedies Year: 2006 Type: Article