Abstract
A liquid chromatographic method for analysis of pazufloxacin mesilate in human plasma and urine has been developed and validated for selectivity, sensitivity, accuracy, precision, and stability in pharmacokinetic analysis. The sensitivity of the method was 0.02 μg mL−1 in plasma and 0.5 μg mL−1 in urine, with overall intra-day and inter-day precision (RSD < 10%) and accuracy (90–120%) acceptable for clinical pharmacokinetic analysis. Recovery from plasma and urine was 80–110% for both pazufloxacin mesilate and enoxacin, the internal standard. Pazufloxacin was stable in both plasma and urine, with no significant degradation under four different conditions. The method was successfully used in a preliminary study of the bioavailability of pazufloxacin mesilate in healthy human volunteers after intravenous administration of 300 and 500 mg.
References
Yamaki K, Hasegawa T, Matsuda I, Nadai M, Aoki H, Takagi K (1997) J Infect Chemother 3:97–102
Nakashima M, Uematsu T, Kosuge K, Tai M, Nakagawa S, Tsuda H (1992) In: Program and Abstract of the 32nd Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, American Society for Microbiology, abstract 656
Totsuka K, Tei M, Kodama K, Yafune A (1996) J Infect Chemother 2:280–282
Hayakawa H, Takagi K, Takano YF, Kawamura Y, Tsuji A (2002) J Pharm Pharmacol 54(9):1229–1236
Zhou S, Ouyang J, Baeyens W, Zhao H, Yang Y (2006) J Chromatogr A 1130:296–301
Wang Y, Baeyens W, Huang C, Fei G, He L, Ouyang J (2009) Talanta 77:1667–1674
Zang Z, Li J, Qu L, Yang R (2008) Chin J Anal Chem 36(7):941–946
Jin J, Zhang X (2008) J Lumin 128:81–86
Chen S, Ma H, Zhao H, Feng R, Jin L (2004) Anal Sci 20:1075–1078
Zhang H, Ren Y, Bao X (2009) J Pharm Biomed Anal 49:367–374
Li Q, Wang R, Pei F (2004) Asian J Drug Metab Pharmacokinet 4:289–293
Yang C, Zhang Z, Chen S, Yang F (2007) Microchim Acta 159:299–304
Zhang Z, Yang G, Wang D, Liang G, Chen Y (2005) J Liq Chromatogr Related Technol 27:813–827
FDA, Guidance for industry, bioanalytical method validation, US Department of Health and Human Services, Center for drug evaluation and research (CDER), 2001; http://www.fda.gov/cder/guidance
Park D, Phapale P, Jang I, Cui S, Moon B, Kim J, Kim W, Hwang S, Yoon Y (2008) Chromatographia 68:187–192
KFDA, Guidance for industry, statistical approaches to establishing bioequivalence. Bioequivalence division, Pharmacology department, National institute of toxicology department, 2003; http://eng.kfda.go.kr/index.php
FDA Guidance for industry, statistical approaches to establishing bioequivalence. US Department of Health and Human Services, Food and Drug Administration, CDER, 2001; http://www.fda.gov/cder/guidance/index.htm
Andriole V (2000) Chemistry and mechanism of action of quinolone antibacterials. In: The Quinolones, 3rd edn. Academic Press, USA, pp 33–96
Kirkland J, Straten A, Claessens H (1998) J Chromatogr A 797:111–120
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This research was supported by a grant from the Korea Health 21 R&D Project, Ministry of Health and Welfare, and the Republic of Korea (A050584).
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P. B. Phapale and H. W. Lee contributed equally to this work.
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Phapale, P.B., Lee, H.W., Kim, SD. et al. Analysis of Pazufloxacin Mesilate in Human Plasma and Urine by LC with Fluorescence and UV Detection, and Its Application to Pharmacokinetic Study. Chroma 71, 101–106 (2010). https://doi.org/10.1365/s10337-009-1408-1
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DOI: https://doi.org/10.1365/s10337-009-1408-1