Relative bioavailability of two formulations of indinavir in Chinese healthy volunteers by reversed phase high performance liquid chromatography
- VernacularTitle:反相高效液相色谱法测定茚地那韦2种制剂在健康人体的相对生物利用度(英文)
- Author:
Hailing QIAO
;
Na GAO
;
Yuzhong GUO
;
Lirong ZHANG
;
Qitang ZHANG
;
Linjing JIA
- Publication Type:Journal Article
- Keywords:
indinavir;
chromatography,high pressure liquid;
pharmacokinetics;
bioequivalence
- From:
Chinese Journal of New Drugs and Clinical Remedies
2005;24(11):841-844
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To establish a method to determine the concentration of indinavir in human plasma and study indinavir bioavailability in Chinese healthy people. METHODS: In a random two-period crossover study, 18 healthy male volunteers received a single dose of indinavir capsules 800 mg of two formulations respectively.A sensitive and specific reversed phase HPLC method was developed to quantitate plasma levels of indinavir. The drug was extracted from plasma with acetonitrile. Analysis was performed on a Hy persil C18 column with a mobile phase of acetonitrile:0.01 mol · L -1 phosphate buffer(pH 5.5 ) (43: 57).The UV detector was set at 210 nm. The standard curve covered the concentration ranged from 0. 03 to 16.38 mg · L-1. RESULTS: The concentration-time curves of reference and tested formulations both fitted to a one-compartment open model. The main pharmacokinetic rameters of tested and reference formulations were (10.6 ±s 2.4) mg· L-1 and (9.8 ±2.2)mg· L-1 for cmax, (0. 71 ± 0. 19) h and (0. 8 ±0.3) h for tmax, (1.30±0.24) h and (1.31 ±0.23) h for t1/2ke, (23±6) mg·h· L-1 and (22±5) mg·h · L-1 forAUC0-10, (24±6) mg · h · L-1 and (22±5) mg · h · L-1 for AUC0-∞, respectively. Two one-sidet test and variance analysis were performed in bioequivalent assessment. No statistically significant difference was found in AUC0-10, AUC0-∞ and cmax values between the tested and reference formulations. CONCLUSION:The reversed phase HPLC is a reliable method to determine the concentration of indinavir in human plasma and the two formulations of indinavir are bioequivalent.
