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KMID : 0369820060360040277
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 4 p.277 ~ p.282
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Bioequivalence of Lisihexal(R) tablet to Zestril(R) tablet (Lisinopril 10 mg)
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오수연/Oh SY
디펜드라쿠마아리얼/조종태/김형건/김윤균/Dipendra Kumar Aryal/Cho JT/Kim HG/Kim YG
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Abstract
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Lisinopril is one of the angiotensin-converting enzyme inhibitors, which have been used for treatment of hypertension and heart failure. The aim of this study was to evaluate the bioequivalence of two lisinopril tablet, Lisihexal® and Zestril® as a test and reference, respectively. The study was came out on 28 healthy male Korean volunteers in 2×2 crossover design. An analytical method with LC-MS-MS was developed for the quantification of lisinopril and enalapril(IS) using SPE method. The condition was selective, sensitive and precise in human plasma, that was enough for the pharmacokinetic study of lisinopril. The pharmacokinetic parameters such as AUCt,AUCinf,Cmax,Tmaxandt1/2 were calculated and ANOVA test was used for the statistical analysis of the parameters using log transformed AUCt,AUCinfandCmax. t1/2 of test and reference drugs were calculated 11.4±5.1and16.1±9.9hr, respectively. The 90% confidence intervals of AUCt,AUCinfandCmax were log 0.9245∼log 1.0603, log 0.9270∼log 1.0601 and log 0.9548∼log 1.1009, within the acceptable range of log 0.8 to log 1.25 by KFDA bioequivalence criteria. Two medications of lisinopril were evaluated bioequivalent and thus may be prescribed interchangeably.
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KEYWORD
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Lisinopril, Enalapril, Bioequivalence, LC-MS-MS
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