YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지
DOI QR코드

DOI QR Code

A Simple HPLC-UV Method for the Quantification of Isepamicin in Human Serum: Pharmacokinetic Applications

HPLC-UV를 이용한 혈청 이세파마이신 정량: 약물동태학적 연구

  • Received : 2015.01.12
  • Accepted : 2015.02.04
  • Published : 2015.02.28
Download PDF
⟨ Previous Next ⟩

Abstract

A simple HPLC-UV method was developed and validated for the quantification of human serum isepamicin using phenylisocyanate as a derivatization agent. The linear calibration curve was obtained in the concentration range of $1{\sim}100{\mu}g/ml$ and LLOQ of $1{\mu}g/ml$. This method was validated with selectivity, linearity, precision and accuracy, leading to successful application for estimating the pharmacokinetic parameters of isepamicin in Korean healthy subjects following IV infusion of 800 mg isepamicin. The mean $t_{1/2}$ of isepamicin was $1.55{\pm}0.08hr$.

Keywords

References

  1. Nagabhushan, T. L., Cooper, A. B., Tsai, H., Daniels, P. J. and Miller, G. H. : The syntheses biological properties of 1-N-(S-4-amino-2-bydroxybutyryl)-gentamicin B and 1-N-(S-3-amino-2-hydroxypropionyl)-gentamicin B. J. Antibiot (Tokyo) 31, 681 (1978). https://doi.org/10.7164/antibiotics.31.681
  2. Tod, M., Padoin, C. and Petitjean, O. : Clinical pharmacokinetics and pharmacodynamics of isepamicin. Clin. Pharmacokinet. 38, 205 (2000). https://doi.org/10.2165/00003088-200038030-00002
  3. Barr, W. H., Colucci, R., Radwanski, E., Zampalione, N., Cutler, D., Lin, C. C., Elliott, M. and Affrime, M. B. : Pharmacokinetics of isepamicin. J. Chemother. 7, 53 (1995).
  4. Miller, G. H., Sabatelli, F. J., Naples, L., Hare, R. S. and Shaw, K. J. : The changing nature of aminoglycoside resistance mechanisms and the role of isepamicin-a new broad-spectrum aminoglycoside. J. Chemother. 7, 31 (1995).
  5. Jones, R. N. : Isepamicin (SCH 21420, 1-N-HAPA Gentamicin B): microbiological characteristics including antimicrobial potency and spectrum of activity. J. Chemother. 7, 7 (1995).
  6. Uematsu, T., Mizuno, A., Suzuki, Y., Sato, R., Yamazaki, T. and Nakashima, M. : Evaluation of fluorescence polarization immunoassay procedure for quantitation of isepamicin, a new aminoglycoside antibiotic. Ther. Drug. Monit. 10, 459 (1988). https://doi.org/10.1097/00007691-198804000-00014
  7. Tod, M., Minozzi, C., Beaucaire, G., Ponsonnet, D., Cougnard, T. and Petitjean, O. : Isepamicin in intensive care unit patients with nosocomial pneumonia: population pharmacokinetic-pharmacodynamic study. J. Chemother. 44, 99 (1999).
  8. Radwanski, E., Batra, V., Korduba, C., Cayen, M., Cutler, D., Affrime, M., Nomeir, A. and Lin, C. C. : Pharmacokinetics of isepamicin following a single administration by intravenous infusion or intramuscular injections. Antimicrob. Agent Chemother. 41, 1794 (1997).
  9. Nomeir, A. A., Radwanski, E., Cutler, D., Lin, C. C., Elliott, M., Affrime, M. B., Christopher, D., Korduba, C., Batra, V. and Cayen, M. N. : Single-dose pharmacokinetics of isepamicin in young and geriatric volunteers. J. Clin. Pharmacol. 37, 1021 (1997). https://doi.org/10.1002/j.1552-4604.1997.tb04283.x
  10. Lin, C. C., Veals, J., Hilbert, M. J., Korduba, C. and Nomeir, A. A. : Analysis of isepamicin in humna plasma by radioimmunoassay, microbiologic assay, and high-performance liquid chromatography. Ther. Drug. Monit. 19, 675 (1997). https://doi.org/10.1097/00007691-199712000-00012
  11. Lin, C. C., Radwanski, E., Korduba, C., Affrime, M. and Cayen, M. : Pharmacokinetics of intramuscularly administered isepamicin in men. Antimicrob. Agent Chemother. 43, 86 (1997).
  12. Maloney, J. A. and Awni, W. M. L High-performance liquid chromatographic determination of isepamicin in plasma, urine and dialysate. J. Chemother. 526, 487 (1990).
  13. Vogel, R., DeFillipo, K. and Rief, V. : Determination of isepamicin sulfate and related compounds by high-performance liquid chromatography using evaporative light scattering detection. J. Pharm. Biomed. Anal. 24, 405 (2001). https://doi.org/10.1016/S0731-7085(00)00465-9
  14. Soltes, L. and Sebille, B. : A simple chiral high performance liquid chromatographic method to study the enantiomer differentiating action of microorganism. An assay with DLtryptophan. Biomed. Chromatogr. 13, 249 (1990).
  15. Hosokawa, S., Nakamura, K., Fujita, Y., Horiuchi, R. and Yamamoto, K. : Determination of isepamicin in human plasma by HPLC with fluorescence detection after derivatization using 6-aminoquinolyl-N-hydroxysuccinimidyl-carbamate. Biol. Pharm. Bull. 31, 1866 (2008). https://doi.org/10.1248/bpb.31.1866
  16. Kim, B. H., Kim, Y. K. and Ok, J. H. : Development of liquid chromatographic method for the analysis of kanamycin residues in varicella vaccine using phenylisocyanate as a derivatization reagent. J. Chromatogr. B. 752, 173 (2001). https://doi.org/10.1016/S0378-4347(00)00506-5
  17. Kim, B. H., Lee, S. C., Lee, H. J. and Ok, J. H. : Reversedphase liquid chromatographic method for the analysis of aminoglycoside antibiotics using pre-column derivatization with phenylisocyanate. Biomed. Chromatogr. 17, 396 (2003). https://doi.org/10.1002/bmc.254
  18. Lee, Y. J., Kim, Y. G., Lee, M. G., Chung, S. J., Lee, M. H. and Shim, C. K. : Analysis of bioequivalence study using logtransformed model, Yakhak Hoeji 44, 308 (2000).
  19. Tod, M., Padoin, C., Minozzi, C., Cougnard, J. and Petitjean, O. : Population pharmacokinetic study of isepamicin with intensive care unit patients, Antimicrob. Agent Chemother. 40, 983 (1996).