Journal of Pharmaceutical Investigation

  • 제35권5호
  • /
  • Pages.375-381
  • /
  • 2005
  • /
  • 2093-5552(pISSN)
  • /
  • 2093-6214(eISSN)
한국약제학회 (The Korean Society of Pharmaceutical Sciences and Technology)
권호 표지
DOI QR코드

DOI QR Code

Simultaneous Determination of Prostaglandin E1 and Prostaglandin E1 Ethyl Ester in Hairless Mouse Skin Homogenate by High-Performance Liquid Chromatography

  • 발행 : 2005.10.20
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

A rapid and specific high-performance liquid chromatographic method was developed and validated for the simultaneous determination of prostaglandin $E_{1}\;(PGE_{1})$ and prostaglandin $E_{1}$ ethyl ester $(PGE_{1}-EE)$ in hairless mouse skin homogenate. The sample treatment procedure involved deproteination and precipitation by acetonitrile. $PGE_{1}$ and $PGE_{1}-EE$ in supernatant were separated in a reversed-phase C18 column without being interfered by other components present in hairless mouse skin homogenate. 9-Anthracenecarboxylic acid was used as an internal standard. The retention times of $PGE_{1}$, 9-anthracenecarboxylic acid and $PGE_{1}-EE$ were, 4.5, 9.5 and 18.0 min, respectively. The assay showed linearity from 1 to $40\;{\mu}g/ml$ for both $PGE_{1}$ and $PGE_{1}-EE$. Precision expressed as RSD ranged from 2.3 to 14.1 % for $PGE_{1}$ and 1.6 to 11.0% for $PGE_{1}-EE$. Accuracy ranged from 100.5 to 119.6 % for $PGE_{1}$ and from 98.0 to 103.7% for $PGE_{1}-EE$. This method was employed successfully to follow the time course of concentrations of $PGE_{1}$ and $PGE_{1}-EE$ in hairless mouse skin homogenate for stability study.

키워드

참고문헌

  1. NIH Concensus Conference, Development Panel on Impotence, JAMA, 270, 83-90 (1993) https://doi.org/10.1001/jama.270.1.83
  2. R.E. Nellans and L.R. Ellis, Pharmacological erection; diagnosis and treatment applications in 69 patients, J. Urol., 138, 52-54 (1987)
  3. P. Halter, Trends in urology, Med Device Diagn. Industry, 12, 52-54 (1990)
  4. J.R. White and R.K. Campbell, Drug induced male sexual dysfunction., U.S. Pharmacist Diabetes Supplement. Complications, November, 44-47(1990)
  5. Y. Mizushima, Lipid microspheres (Lipid emulsions) as a drug carries-overview, Adv. Drug Del. Rev., 20, 113-115 (1996) https://doi.org/10.1016/0169-409X(95)00114-M
  6. R. Igarashi, T. Tdenenaga, T. Matsuda, Distribution of lipid microsphere preparations, Adv. Drug Del. Rev., 20, 147-154 (1996) https://doi.org/10.1016/0169-409X(95)00125-Q
  7. H. Porst, The rationale for prostaglandin $E_1$ in erectile failure: a survey of worldwide experience, J. Urol., 155, 802-815 (1996) https://doi.org/10.1016/S0022-5347(01)66315-8
  8. O.I. Linet and F.G. Orrinc, Efficacy and safety of intracavernosal alprostadil in men with erectile dysfunction, N. Engl. J. Med., 334, 873-877 (1996) https://doi.org/10.1056/NEJM199604043341401
  9. J.D. Engel and K.T. McVary, Transurethral alprostadil as therapy for patients who withdrew from or failed prior intracavernous injection therapy, Urology, 51, 687-692 (1988) https://doi.org/10.1016/S0090-4295(98)00093-4
  10. E.D. Kim and K.T. McVary, Topical prostaglandin $E_1$ for the treatment of erectile dysfunction, J. Urol.15, 3, 1828-1830 (1995)
  11. M. Maggi, S. Filippe and F. Ledda, Erectile dysfunction: from biochemical pharmacology to advances in medical therapy, Eur. J. Endocrinol., 143, 143-154 (2000) https://doi.org/10.1530/eje.0.1430143
  12. H. Wendel and F.J. Braun, Transdermal prostaglandin composition, U.S. Patent, 5, 380, 760 (1995)
  13. M.T. Sheu, L.-H. Lin, B.W. Spur, P.Y.-K. Wong and H.-S. Chiang, Investigation of the percutaneous penetration of prostaglandin $E_1$ and its ethyl ester, J. Control. Rel., 55, 153-160 (1998) https://doi.org/10.1016/S0168-3659(98)00045-5
  14. United States Pharmacopeia 23, Section 1225,'Validation of Compendial Methods,' United States Pharmacopeia Convention, Inc., Rockville, MD, 1995
  15. F. BressolIe, M. Bromet-Petit and M. Audran, Validation of liquid chromatographic and gas chromatographic methods. Applications to pharmacokinetics, J. Chromatogr. B, 686, 3-10 (1996) https://doi.org/10.1016/S0378-4347(96)00088-6
  16. G.W. Peng and W.L. Chiou, Analysis of drugs and other toxic substances in biological samples for pharmacokinet studies, J. Chromatogr. B, 531, 3-50 (1990) https://doi.org/10.1016/S0378-4347(00)82279-3
  17. A. Parra, J. Garcia-Villanova, V. Rodenas and MD. Gomez, First and second derivative spectrophotometric determination of cefoperazone and sulbactam in injections, J. Pharm. Biomed. Anal., 12, 653-657 (1994) https://doi.org/10.1016/0731-7085(93)E0022-F
  18. H. Mahgoub and F.A. Aly, UV-spectrophotometric determination of ampicillin sodium and sulbactam sodium in two-component mixtures, J. Pharm. Biomed. Anal., 17, 1723-1728 (1998)
  19. H. Rosing, Y.W. Man, E. Doyle, A. Buh and J.H. Beijnen, Bioanalytical liquid chromatographic method validation: a review of current practices and procedures, J. Liq. Chromatogr. Related Technol., 23, 329-354 (2000) https://doi.org/10.1081/JLC-100101455
  20. International Conference on Harmonization, Note for Guidance on Validation of Analytical Procedures: Methodology, Committee for Proprietary Medical Products, CPMP/ICH/281/ 95 Approval 18 December, 1996
  21. S. Braggio, R.J. Barnaby, P. Grossi and M. Cugola, A strategy for validation of bioanalytical methods, J. Pharm. Biomed. Anal. 14, 375-388 (1996) https://doi.org/10.1016/0731-7085(95)01644-9
  22. S. Ahmed, T. Imai and M. Otagiri, Stereoselective hydrolysis and penetration of propranolol prodrugs: in vitro evaluation using hairless mouse skin, J. Pharm. Sci., 84, 877-883 (1995) https://doi.org/10.1002/jps.2600840718
  23. C. Hartmann, J. Smeyers-Verbeke, D.L. Massart and R.D. McDowall, Validation of bioanalytical chromatographic methods, J. Pharm. Biomed. Anal., 17, 193-218 (1998) https://doi.org/10.1016/S0731-7085(97)00198-2
  24. Ph. Hubert, P. Chiap, J. Crommen, B. Boulanger, E. Chapuzet, N. Mercier and S. Bervoas-Martin, P. Chevalier, D. Grandjean, P. Lagorce, M. Lallier, M.C. Laparra, M. Laurentie and J.C. Nivet, The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington conference to the laboratory, Analytica Chimica Acta, 391, 135-148 (1999) https://doi.org/10.1016/S0003-2670(99)00106-3
  25. R.H. Guy, Current status and future prospects of transdermal drug delivery, Pharm. Res., 13, 1765-1768 (1996) https://doi.org/10.1023/A:1016060403438
  26. K.B. Sloan, Prodrugs for dermal delivery, Adv. Drug Del. Rev., 3, 67-101 (1989) https://doi.org/10.1016/0169-409X(89)90005-7
  27. J. Rautio, H. Taipale and J. Gynther, In vitro evaluation of acyloxyalkyI ester as dermal prodrugs of detoprofen and naproxen, J. Pharm. Sci., 87, 1662-1628 (1998)
  28. G.B. Kasting, R.L. Smith, B.D. Andersom, K.B. Sloan and M.C. Dekker, Prodrugs for dermal Delivery; Solubility, Molecular Size, and Functional Group Effects. In Prodrugs, Topical and Ocular Drug Delivery, New York, 117-161(1992)