Roxithromycin capsule in human pharmacokinetics and bioequivalence of.docVIP

 PAGE \* MERGEFORMAT 13 Roxithromycin capsule in human pharmacokinetics and bioequivalence of Author: You Hai-sheng, Dong Ya-Lin, Wang Maoyi, DONG Wei-hua, Zheng Xin 【Abstract】 Objective To establish the concentration of roxithromycin in human plasma by high performance liquid analytical methods used to study the roxithromycin capsule in human pharmacokinetics and bioequivalence. Methods Plasma samples were used  hexane isoamyl alcohol (98:2) liquid  liquid extraction, reversed-phase HPLC method. The results of roxithromycin in the linear range of 0.25-32.06mg / L (r is 0.9992), the minimum detectable concentration of 0.25mg / L, the minimum detectable amount of 12.5ng, extraction recoveries were 68.0% -72.8% , method recovery was 90.7% -99.4%. A single dose of 300mg capsules Roxithromycin subjects after preparation or reference preparation pharmacokinetic parameters AUC0-48h, Cmax, tmax, t1 / 2 were (101.84 ± 27.69) (mg * h) / L and (103.5 ± 30.83) (mg * h) / L, (8.54 ± 1.95) mg / L and (8.07 ± 1.81) mg / L, (1.6 ± 0.6) h and (1.8 ± 0.6) h, (10.4 ± 2.9) h, and (10.5 ± 2.6) h. Subjects relative bioavailability of formulation (100.5 ± 19.1)%. Conclusion This method is good specificity, endogenous plasma impurities without interference results are accurate. Roxithromycin the two formulations of major pharmacokinetic parameters no significant difference in bioequivalent. Keywords: roxithromycin; HPLC; bioequivalence; pharmacokinetics Pharmacokinetics and bioequivalence of roxithromycin capsules in human ABSTRACT: Objective To establish the method of assaying roxithromycin in human plasma by high performance liquid chromatography (HPLC), and to study its pharmacokinetics and bioequivalence. Methods The plasma samples were extracted by hexane isoamylalcohol (98:2) and reversed phase chromatography to determine the concentration of roxithromycin. Results The calibration curve was linear from 0.25mg / L to 32.06mg / L, the minimum conce