Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Vardenafil and Its Application of Bioequivalence

Table 7

Pharmacokinetic parameters of the optimized formulation of vardenafil orodispersible tablet (test) and marketed orodispersible tablet formulation (reference) in New Zealand white rabbit.

	(h)	(ng/mL)	(ng·h/mL)	(ng·h/mL)	(h)
Formulation T
N			12
Mean	1.42 ± 0.19	75.36 ± 59.53	174.38 ± 95.91	174.38 ± 95.91	4.83 ± 1.63
Min	1.00	21.74	63.22	63.22	1.43
Median	1.50	72.79	163.12	163.12	5.12
Max	1.50	240.20	393.13	393.13	6.64
CV%	13.74	78.99	54.99	54.99	33.85
Geometric mean	1.40	59.18	150.88	150.88	4.45
Formulation R
N			12
Mean	2.04 ± 0.33	58.21 ± 36.11	176.45 ± 76.88	176.45 ± 76.88	4.75 ± 0.85
Min	1.50	13.15	66.47	66.47	3.42
Median	2.00	46.24	171.18	171.18	4.63
Max	3.00	140.96	295.46	295.46	5.88
CV%	16.37	62.03	43.57	43.57	17.99
Geometric mean	2.02	48.63	159.56	159.56	4.68

R indicates reference; T indicates test; h indicates time in hours; ng indicates nanogram; mL indicates milliliters; AUC_0-t indicates the measured AUC from 0 to 24 h; indicates area under the curve until infinite; N indicates numbers of rabbits; SD indicates standard deviation; CV indicates coefficient variation; indicates time to reach the maximum peak; indicates the maximum concentration that achieved; indicates the half-life of the drug.