Application of a Reliable LC-MS/MS Method for Determination of Rizatriptan in Healthy Subject Samples: Demonstration of Assay Reproducibility by Incurred Sample Reanalysis

Table 4

(a) Mean pharmacokinetic parameters after oral administration of 10 mg rizatriptan orally disintegrating tablet formulation to 40 and 32 healthy Indian subjects under fasting and fed conditions, respectively. (b) Comparison of treatment ratios and 90% CIs of natural log- (Ln-) transformed parameters for test and reference 10 mg orally disintegrating tablet formulations of rizatriptan in 40 and 32 healthy Indian subjects under fasting and fed conditions, respectively.

(a)

Parameter	Fasting		Fed
	Test	Reference	Test	Reference
	Mean ± SD	Mean ± SD	Mean ± SD	Mean ± SD
𝐶max (ng /mL)	22.69 ± 6.49	21.93 ± 5.85	21.62 ± 5.56	21.10 ± 5.63
𝑇max (h)	1.51 ± 0.69	1.62 ± 0.85	2.11 ± 0.85	2.01 ± 0.65
𝑡1/2 (h)	1.91 ± 0.25	1.90 ± 0.26	2.01 ± 0.24	2.03 ± 0.24
AUC0-24h (h·ng/mL)	88.72 ± 22.00	86.26 ± 20.50	92.69 ± 21.00	93.36 ± 23.09
AUC0-inf (h·ng/mL)	89.56 ± 22.09	87.13 ± 20.63	93.66 ± 21.07	94.27 ± 23.16
𝐾el (1/h)	0.369 ± 0.045	0.372 ± 0.050	0.351 ± 0.046	0.346 ± 0.039

𝐶_max: maximum plasma concentration; 𝑇_max: time point of maximum plasma concentration.
𝑡_1/2: half-life of drug elimination during the terminal phase.
AUC_0-𝑡: area under the plasma concentration—time curve from zero hour to 24 h.
AUC_0-inf: area under the plasma concentration—time curve from zero hour to infinity.
𝐾_el: elimination rate constant; SD: standard deviation.

(b)

Parameter	Ratio (test/reference), %		90% CI (lower–upper)		Power		Intrasubject variation, % CV
	Fast	Fed	Fast	Fed	Fast	Fed	Fast	Fed
Ln 𝐶max (ng/mL)	103.1	102.9	95.1–111.7	96.3–110.0	0.9974	0.9998	21.41	14.57
Ln AUC0-24 (h·ng/mL)	102.7	100.1	98.8–106.7	96.6–103.7	1.000	1.000	10.15	7.72
Ln AUC0-inf (h·ng/mL)	102.6	100.1	98.8–106.6	96.7–103.7	1.000	1.000	10.06	7.64

CI: confidence interval; CV: coefficient of variation.