Skip to main content
Log in

Analysis of Pazufloxacin Mesilate in Human Plasma and Urine by LC with Fluorescence and UV Detection, and Its Application to Pharmacokinetic Study

  • Full Short Communication
  • Published:
Chromatographia Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

References

  1. Yamaki K, Hasegawa T, Matsuda I, Nadai M, Aoki H, Takagi K (1997) J Infect Chemother 3:97–102

    Article  CAS  Google Scholar 

  2. 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

  3. Totsuka K, Tei M, Kodama K, Yafune A (1996) J Infect Chemother 2:280–282

    Article  Google Scholar 

  4. Hayakawa H, Takagi K, Takano YF, Kawamura Y, Tsuji A (2002) J Pharm Pharmacol 54(9):1229–1236

    Article  CAS  Google Scholar 

  5. Zhou S, Ouyang J, Baeyens W, Zhao H, Yang Y (2006) J Chromatogr A 1130:296–301

    Article  CAS  Google Scholar 

  6. Wang Y, Baeyens W, Huang C, Fei G, He L, Ouyang J (2009) Talanta 77:1667–1674

    Article  CAS  Google Scholar 

  7. Zang Z, Li J, Qu L, Yang R (2008) Chin J Anal Chem 36(7):941–946

    Article  Google Scholar 

  8. Jin J, Zhang X (2008) J Lumin 128:81–86

    Article  CAS  Google Scholar 

  9. Chen S, Ma H, Zhao H, Feng R, Jin L (2004) Anal Sci 20:1075–1078

    Article  CAS  Google Scholar 

  10. Zhang H, Ren Y, Bao X (2009) J Pharm Biomed Anal 49:367–374

    Article  CAS  Google Scholar 

  11. Li Q, Wang R, Pei F (2004) Asian J Drug Metab Pharmacokinet 4:289–293

    Google Scholar 

  12. Yang C, Zhang Z, Chen S, Yang F (2007) Microchim Acta 159:299–304

    Article  CAS  Google Scholar 

  13. Zhang Z, Yang G, Wang D, Liang G, Chen Y (2005) J Liq Chromatogr Related Technol 27:813–827

    Article  Google Scholar 

  14. 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

  15. Park D, Phapale P, Jang I, Cui S, Moon B, Kim J, Kim W, Hwang S, Yoon Y (2008) Chromatographia 68:187–192

    Article  CAS  Google Scholar 

  16. 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

  17. 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

  18. Andriole V (2000) Chemistry and mechanism of action of quinolone antibacterials. In: The Quinolones, 3rd edn. Academic Press, USA, pp 33–96

  19. Kirkland J, Straten A, Claessens H (1998) J Chromatogr A 797:111–120

    Article  CAS  Google Scholar 

Download references

Acknowledgments

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).

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Young-Ran Yoon.

Additional information

P. B. Phapale and H. W. Lee contributed equally to this work.

Rights and permissions

Reprints and permissions

About this article

Cite this article

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

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1365/s10337-009-1408-1

Keywords

Navigation