Urine Drug Level Determined by HPLC and the Bioequivalence of Alendronate Sodium Tablets in Healthy Volunteers
- VernacularTitle:HPLC法测定阿仑膦酸钠的尿药浓度及其生物等效性研究
- Author:
Jie ZHOU
;
Peng SUN
;
Qing REN
- Publication Type:Journal Article
- Keywords:
Alendronate sodium tablets;
HPLC;
Urine drug level;
Bioequivalence
- From:
China Pharmacy
2007;0(35):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the bioequivalence of Alendronate Sodium Tablets in healthy volunteers. METHODS:According to a paired and cross-over design,a bioequivalence test was performed on two different alendronate sodium tablets,10 mg (Group 1) and 70 mg (Group 2). Then each group was subdivided into two groups,i.e. test preparation and reference preparation. The urine concentrations of alendronate at different time point within 48 h were determined by HPLC and the urine excretion rate -time curve was drawn,and the DAS software was used to compute the pharmacokinetic parameters and the relative bioavailability of the tested formulation. RESULTS:The 90% confidence intervals of urine excretion rate of the tested formulations were 82.4% ～122.6% (Group 1) and 85.4% ～124.6% (Group 2),respectively and the maximum excretory rates were 80.3% ～131.5% (Group 1) and 82.3～136.5% (Group 2),respectively,compared with the reference formulations. CONCLUSION:The two different Alendronate Sodium Tablets and their respective reference formulations were proved to be bioequivalent in healthy volunteers.
