Liquid chromatography-tandem mass spectrometry method for determination of Sirolimus coated drug eluting nano porous carbon stents

Biomedical Chromatography

Volumn 24, Issue 3, 2010, Pages 329-334

  Rajender, G ^a,b   Narayanan, N G B ^b  

^a Relisys Medical Devices Ltd ^*  (India)

^b Research and Development Division   (India)

Author keywords

Liquid chromatography tandem mass spectrometry; Nano porous carbon stents; Pharmacokinetic; Sirolimus

Indexed keywords

CARBON; CHLORINE COMPOUNDS; CONTROLLED DRUG DELIVERY; ELECTROSPRAY IONIZATION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; ORGANIC SOLVENTS; POROUS MATERIALS; STENTS; TARGETED DRUG DELIVERY;

DRUG-ELUTING STENTS; HIGH SELECTIVITY; LC-MS-MS; LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY; LIQUID CHROMATOGRAPHY/TANDEM MASS SPECTROMETRY; NANO POROUS CARBON STENT; NANO-POROUS; POROUS CARBONS; RESEARCH TOOLS; SIROLIMUS;

PHARMACOKINETICS;

ACETIC ACID; RAPAMYCIN;

ARTICLE; CHROMATOGRAPHY; DRUG ELUTING STENT; DRUG RELEASE; ELUTION; FLOW RATE; HUMAN; IMPLANTATION; IN VITRO STUDY; KINETICS; LIQUID CHROMATOGRAPHY; SENSITIVITY ANALYSIS; STENT; TANDEM MASS SPECTROMETRY; ULTRAVIOLET RADIATION;

EID: 76149089855     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.1295     Document Type: Article

References (25)

1. Bierer BE, Matilla PS, Staendert RF, Herzenberg LA, Burakoff SJ, Crabtree G and Schreliber SL.Two distinct transmission pathways in T Lymphocytes are inhibited by complexes formed between an immunophilin and either FK 506 or rapamycin. Proceedings of the national Academy of Sciences U S A 1990; 87: 9231.
2. FDA. Guidance for industry: Bioanalytical Method Validation, May 2001.
3. Ferron GM and Jusko WJ. Species difference in sirolimus stability in humans, rabbits and rats. Drug Metabolism and Disposition 1998; 26: 83.
4. Fischman DL, Leon MB, BaimDS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D and Nobuyoshi M. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. New England Journal of Medicine 1994; 331: 496.
5. Groth CG, Backman L, Morales J-L, Calne R, Kreis H and Lang P. Sirolimus (rapamycin)-based therapy in human renal transplantation. Transplantation 1999; 67: 1036.
6. Holt DW, Leef T and Johnston A. Validation of an assay for routine monitoring of sirolimus using HPLC with mass spectrometric detection. Clinical Chemistry 2000; 46:1179.
7. Kahan B. Pivotal phase |||multicenter, randomized, blinded trail of sirolimus vs. azathioprine in combination with cyclosporine and prednisone in primary renal transplants. Transplantation 1999; 67: 68.
8. Kahan BD, Chang J and Sehgal SN. Preclinical evaluation of a new immunosuppressive agent, rapamycin. Transplantation 1991; 52: 185.
9. Kahan BD, Julian B, Pescovitz MD, Vanrenterghem Y and Neylan J. For the Sirolimus Study Group. Sirolimus (rapamycin) phase ||study: low incidence of acute rejection in recipients of mismatched primary renal allografts. Transplantation 1999; 68: 1526.
10. Kahan BD, Napoli KL, Kelly PA, Podbielski J, Hussein L and Urbauer DL. Therapeutic drug monitoring of sirolimus: correlations with effi cacy and toxicity. Clinical Transplantation 2000; 14: 97.
11. Lafont A and Faxon D. Why do animal models of post-angioplasty restenosis sometimes poorly predicted the outcome of clinical trials? Cardiovasular Research 1998; 39: 50.
12. MacDonald A. A randomized trial of sirolimus, cyclosporine and prednisone vs. cyclosporine and prednisone alone in recipients of mismatched fi rst kidney grafts: results at one year. Transplantation 1999; 67: 5546.
13. Maleki S, Graves S, Becker S, Horwatt R, Hicks D, Stroshane RM and Kincaid H. Therapeutic monitoring of sirolimus in human whole blood samples by high-performance liquid chromatography. Clinical Therapeutics 2000; 22: 25.
14. Morris RE. Rapamycin: antifungal, antitumor, antiproliferative, and immunosuppressive macrolides. Transplantation Reviews 1992; 6: 39.
15. Napoli KL and Kahan BD. Routine clinical monitoring of sirolimus (rapamycin) whole blood concentrations by HPLC with ultraviolet detection. Clinical Chemistry 1996; 42: 1943.
16. Serruys, PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V and Materne PA. Comparision of balloon expandable stent implantation with balloon angioplasty in patients with coronary artery disease. New England Journal of Medicine 1994; 331: 489.
17. Sevensson J, Brattstrom C and Sawe J. Determination of rapamycin in whole blood by HPLC. Therapeutic Drug Monitoring 1997; 19: 112.
18. Sehgal SN, Baker H and Vezina C. Rapamycin (AY-22,989), a new antifungal antibiotic. ||.Fermentation, isolation and characterization. Journal of Antibiotics 1975; 28: 727.
19. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skel.ly JP and Yacobi A. Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies Journal of Pharmaceutical Sciences 1992; 81: 309.
20. Stattler M, Guengerich FP, Yun CH, Christians U and Sewing KF. Cytochrome P-450 3A enzymes are responsible for biotransformation of FK-506 and rapamycin in man and rat. Drug Metabolism and Disposposition 1992; 20: 753.
21. Stepkowski SM, Chen H, Daloze P and Kahan BD. Rapamycin, a potent immunosuppressive drug for vascularized hear, kidney and small bowel transplantation in the rat. Transplantation 1991; 51: 22.
22. Vezina C, Kudelski A and Sehgal SN. Rapamycin (AY-22,989) a, new antifungal antibiotic. |.Taxonomy of the producing streptomycete and isolation of the active principle. Journal of Antibiotics 1975; 28: 721.
23. Yatscoff RW, Boeckx R, Holt DW, Kahan BD, Legatt DF and Sehagal S. Consensus guidelines for therapeutic drug monitoring of rapamycin: report of the consecsus panel Therapeutic Drug Monitoring 1995; 17: 676.
24. Yatscoff RW, Faraci CJ and Bolingbroke P. Measurement of rapamycin in whole blood using reverse-phase high performance liquid chromatography. Therapeutic Drug Monitoring 1992; 14: 138.
25. Zimmerman JJ and Kahan BD. Pharmacokinetics of sirolimus in stable renal transplant patients after multiple oral dose administration. Journal of Clinical Pharmacology 1997; 37: 405.