Of andrographolide in human plasma by HPLCMS determination and bioavailability study of.doc

 PAGE \* MERGEFORMAT 12 Of andrographolide in human plasma by HPLCMS determination and bioavailability study of Authors: Zhang Zhihua, He Kang Zhou, Zhou Yanbin, Li Yuhong, Juan Tian, Zuo Ying, Ding Jinsong [Abstract] Objective: To establish andrographolide in human plasma by the HPLC  MS assay to study the two kinds of andrographolide relative bioavailability of the dispersible tablets. Methods: Plasma samples were liquid-liquid extraction was conducted after the LC  MS analysis, chromatographic HANBANG C18 column (4.6 mm * 150 mm, 5 μ m), mobile phase was methanol  water (72:28, v / v), detection of ion of m / z 373. 6 (andrographolide), m / z 267.7 (nevirapine, internal standard). 20 healthy volunteers were randomized crossover manner a single oral tablet andrographolide T or R the 0.15 g, taken at different time points, blood samples for the newly established HPLC  MS determination, study compared the pharmacokinetics of two formulations parameters and relative bioavailability. Results: andrographolide in the 1.343 ~ 268.6 μ g / L concentration range with the peak area ratio of good linearity, minimal detectable concentration of 1.343 μ g / L. The recoveries of 95.7% ~ 104.7%, day RSD less than 6.4%, day RSD less than 12.4%. A single oral dose of andrographolide tablet T, and R 0.15 g of the Cmax for the latter two agents (114.26 ± 37.20) μ g / L, (107.95 ± 32.44) μ g / L,; Tmax of (1.0 ± 0.3) h, (1.1 ± 0.3) h; AUC0  36 to (375.96 ± 89.86) μ g * h / L, (368.84 ± 89.14) μ g * h / L; AUC0  ∞ of (388.39 ± 91.14) μ g * h / L, (382.81 ± 97.14 ) μ g * h / L; T1 / 2 of (7.65 ± 2.24) h, (7.90 ± 2.16) h. Conclusion: This method is good selectivity and high sensitivity, can be used for the process of andrographolide in vivo studies. The pharmacokinetic parameters of variance analysis showed that andrographolide tablet T and R in the andrographolide main difference between the pharmacokinetic parameters were not statistically significant,