DOI QR코드

DOI QR Code

Validation of a Simple HPLC Method for Determination of Ciprofloxacin Hydrochloride in Human Plasma

인체 혈장에서 염산시프로플록사신(시프로플록사신으로서 250 mg) 정량을 위한 HPLC 분석법의 유효성검토

  • Published : 2004.08.20

Abstract

A simple HPLC method with ultraviolet detection of ciprofloxacin in human plasma was developed and validated. After protein precipitation with trichloroacetic acid, chromatographic separation of ciprofloxacin in plasma was achieved at $50^{\circ}C$ with a $C_{18}$ column and methanol-phosphate mixture (pH 2.5), as mobile phase. Quantitative determination was performed by ultraviolet detection at 278 nm. The method was specific and validated with a limit of quantification of 100 ng/ml. The intra- and inter-day coefficients of variation were between 1.67% and 10.55% and accuracy between 92.01 % and 106.09%. The method has been successfully applied in a bioavailability study of 250 mg ciprofloxacin hydrochloride tablet.

Keywords

References

  1. T.L. Ke, G. Cagle, B. Schlech, O.J. Lorenzetti, and J. Mattern,Ocular bioavailability of ciprofloxacin in sustained release formulations, J. Ocul. Pharmacol. Ther., 17, 555-563 (2001) https://doi.org/10.1089/10807680152729248
  2. A. El-Yazigi and S. Al-Rawithy, A direct liquid chromato-graphic quantitation of ciprofloxacin in microsamples of plasma with fluorometric detection, Ther. Drug Monit., 12, 378-381 (1990) https://doi.org/10.1097/00007691-199007000-00014
  3. A. Weber, D. Chaffin, A. Smith, and K.E. Opheim, Quanti-tation of ciprofloxacin in body fluids by high-pressure liquid chromatography, Antimicrob. Agents Chemother., 27, 531-534 (1985) https://doi.org/10.1128/AAC.27.4.531
  4. S.J. Morton, V.H. Shull, and J.D. Dick, Determination of norfloxacin and ciprofloxacin concentrations in serum and urine by high-performance liquid chromatography, Antimicrob. Agents Chemother., 30, 325-327 (1986) https://doi.org/10.1128/AAC.30.2.325
  5. G. Mack, Improved high-performance liquid chromatographic determination of ciprofloxacin and its metabolites in human specimens, J. Chromatogr., 582, 263-267 (1992) https://doi.org/10.1016/0378-4347(92)80331-J
  6. B.B. Ba, D. Ducint, M. Fourthillan, and M.e. Saux, Fully automated high-performance liquid chromatography of ciprofloxacin with direct injection of plasma and Mueller-Hinton broth for pharmacokinetic/pharmacodynamic studies, J. Chromatogr. B, 714, 317-324 (1998) https://doi.org/10.1016/S0378-4347(98)00192-3
  7. F. Jehl, C. Gallon, J. Debs, J.M. Brogard, H. Monteil, and R. Minck, High-performance liquid chromatographic method for determination of ciprofloxacin in biological fluids, J. Chromatogr., 339, 347-357 (1985) https://doi.org/10.1016/S0378-4347(00)84662-9
  8. W.M. Awni, J Clarkson, and D.R.P. Guay, Determination of ciprofloxacin and its 7-ethy1enediamine metabolite in human serum and urine by high~performance liquid chromatography, J. Chromatogr., 419, 414-420 (1987) https://doi.org/10.1016/0378-4347(87)80309-2
  9. Y.Y. Pei, X. Meng, and C.H. Nightingale, An improved HPLC assay for ciprofloxacin in biological samples, Acta Pharmacol. Sinica, 15, 197-201 (1994)
  10. M. Kamberi, N. Hajime, P. Kamberi, N. Demura, K. Nakamura, and S. Nakano, Simultaneous determination of grepafloxacin, ciprofloxacin, and theophylline in human plasma and urine by HPLC, Ther. Drug Monit., 21, 335-340 (1999) https://doi.org/10.1097/00007691-199906000-00016
  11. J.A. Morley and L. Elrod, Determination of fluoroquinolone antibacterials as N-acyl derivatives, Chromatographia, 37, 295-299 (1993)
  12. 식품의약품안전청 고시 제 2001-57호(2001. 9. 5). 생물학적동등성시험기준
  13. Y. Escobar and C. Hoyo-Vadillo, Pharmacokinetics of cipro-floxacin in healthy Mexican volunteers, Armeimittel-forschung, 53, 664-667 (2003)
  14. R. Bellmann, P. Egger, W. Gritsch, R. Bellmann-Weiler, M. Joannidis, S. Dunzendorfer, and Chl Wiedermann, Pharma-cokinetics of ciprofloxacin in patients with acute renal failure undergoing continuous venovenous haemofiltration: influence of concomitant liver cirrhosis. Acta. Med. Austriaca, 29, 112-116 (2002) https://doi.org/10.1046/j.1563-2571.2002.02017.x
  15. T. Bergan, A. Dalhoff, and R. Rohwedder, Pharmacokinetics of Ciprofloxacin, Infection, 16, 3-13 (1988)