Bioequivalence of Samchundang Lercanidipine Tablet 10 mg to Zanidip Tablet (Lercanidipine Hydrochloride 10 mg) by Liquid Chromatography with Tandem Mass Spectrometry |
Kim, Se-Mi
(College of Pharmacy and Institute of Bioequivalence and Bridging Study, Chonnam National University)
Kim, Hwan-Ho (College of Pharmacy and Institute of Bioequivalence and Bridging Study, Chonnam National University) Shin, Sae-Byeok (College of Pharmacy and Institute of Bioequivalence and Bridging Study, Chonnam National University) Kang, Hyun-Ah (College of Pharmacy and Institute of Bioequivalence and Bridging Study, Chonnam National University) Cho, Hea-Young (General Pharmacology Team, Pharmacological Research Department, NITR, KFDA) Kim, Yoon-Gyoon (College of Medicine, Dankook University) Lee, Yong-Bok (College of Pharmacy and Institute of Bioequivalence and Bridging Study, Chonnam National University) |
1 | K.J. McClellan and B. Jarvis, Lercanidipine: a review of its use in hypertension, Drugs, 60, 1123-1140 (2000) DOI |
2 | L.M. Bang, T.M. Chapman and K.L. Goa, Lercanidipine: a review of its efficacy in the management of hypertension, Drugs, 63, 2449-2472 (2003) DOI |
3 | M. Epstein, Lercanidipine: a novel dihydropyridine calciumchannel blocker, Heart Dis., 3, 398-407 (2001) |
4 | The Martindale, 32rd, ed., Pharmaceutical Press, pp. 897 (1999) |
5 | M. Barchielli, E. Dolfmi, P. Farina, B. Leoni, G Targa, V. Vinaccia and A. Tajana, Clinical pharmacokinetics of lercanidipine, J. Cardiovasc. Pharmacol., 29 (suppl 2): S1-S15 (1997) DOI ScienceOn |
6 | K-BE Test 2002 for Window, Y.J. Lee, S.J. Jung and C.K. Shim, Version 1.2.1. (2002) |
7 | Guidance for Industry-Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Adaministration, Center for Drug Evaluation and Research, Center for Verternary Medicine, May 2001, http://www. fda.gov/cder/guidance/index.htrn |
8 | Korea Food & Drug Administration, Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, Bioequivalence Division, Pharmacology Department, National Institute of Toxicology Department, 2005, http://www.kfda. go.kr |
9 | I.I. Salem, J. Idrees, J.I. Al Tamimi and P. Farina, Selective and rapid liquid chromatography-mass spectrometry method for the determination of lercanidipine in human plasma, J. Chromatogr. B. Analyt. Technol. Biomed Life Sci., 25, 201217 (2004) |
10 | S.M. Kim, H.H. Kim, S.B. Shin, H.A. Kang, H. Yoon, H.Y. Cho, Y.G Kim, C.W. Yang, C.S. Yong and Y.B. Lee, Validation of an LC/MS/MS method for the pharmacokinetic study of lercanidipine, J. Kor. Pharm. Sci., 37, 223-227 (2007) 과학기술학회마을 |
11 | V.A.P. Jabor, E.B. Coelho, D.R. Ifa, P.S. Bonato, N.A. dos Santos and V.L. Lanchote, Enantioselective determination of lercanidipine in human plasma for pharmacokinetic studies by normal-phase liquid chromatography-tandem mass spectrometry, J. Chromatogr. B. Analyt. Technol. Biomed Life Sci., 796, 429-437 (2003) DOI ScienceOn |
12 | Korea Food & Drug Administration Notification No. 200531, Standard Protocol of Bioequivalence Test (2005. 06. 07) |
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