Reference

Study on HPLC determination of indinavir sulfate capsules in human plasma and its pharmacokinetics

All Rights Reserved. Study on HPLC determination of indinavir sulfate capsules in human plasma and its pharmacokinetics. Liu, Fengqin; Li, Kexin; Sun, Chunhua (Beijing Hospital, Ministry of Health, Beijing 100730, Peop. Rep. China). Zhongguo Yiyuan Yaoxue Zazhi, 25(9), 812-814 (Chinese) 2005 Zhongguo Yiyuan Yaoxue Zazhi Bianjibu. CODEN: ZYYAEP. ISSN: 1001-5213. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) The pharmacokinetic characters of indinavir sulfate capsules in human plasma were studied. The plasma concn. of indinavir sulfate was detd. by RP-HPLC method following a single oral dose of 800 mg in an open randomized design. The main pharmacokinetic parameters of the test were as follows: tmax was (0.55±0.11) h, t1/2a was (1.03±0.19) h, Cmax was (18.4±4.8) mg×L-1, AUC0-t was (34.9±14.2) mg × L-1 × h resp. The study provides useful information for clin. trails.Except for chemicals metioned above, 157810-81-6 is also used. .

Relative bioavailability of two formulations of indinavir in Chinese healthy volunteers by reversed phase high performance liquid chromatography

All Rights Reserved. Relative bioavailability of two formulations of indinavir in Chinese healthy volunteers by reversed phase high performance liquid chromatography. Qiao, Hai-ling; Gao, Na; Guo, Yu-zhong; Zhang, Li-rong; Zhang, Qi-tang; Jia, Lin-jing (Institute of Clinical Pharmacology, Zhengzhou University, Zhengzhou, He-nan 450052, Peop. Rep. China). Zhongguo Xinyao Yu Linchuang Zazhi, 24(11), 841-844 (English) 2005 Zhongguo Xinyao Yu Linchuang Zazhi Zazhishe. CODEN: ZXYLBE. ISSN: 1007-7669. 157810-81-6 are also occured in this study. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) AIM: To establish a method to det. the concn. 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 resp. A sensitive and specific reversed phase HPLC method was developed to quantitate plasma levels of indinavir. The drug was extd. from plasma with acetonitrile. Anal. was performed on a Hypersil 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 std. curve covered the concn. ranged from 0.03 to 16.38 mg × L-1. RESULTS: The concn.-time curves of ref. and tested formulations both fitted to a one-compartment open model. The main pharmacokinetic parameters of tested and ref. 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 for AUC0-10, (24 ± 6) mg × h × L-1 and (22 ± 5) mg × h × L-1 for AUC0-￥, resp. Two one-side t test and variance anal. were performed in bioequivalent assessment. No statistically significant difference was found in AUC0-10, AUC0-￥ and cmax values between the tested and ref. formulations. CONCLUSIONS: The reversed phase HPLC is a reliable method to det. the concn. of indinavir in human plasma and the two formulations of indinavir are bioequivalent. .