Fast and sensitive determination of Polysorbate 80 in solutions containing proteins

Journal of Pharmaceutical and Biomedical Analysis

Volumn 52, Issue 5, 2010, Pages 672-679

  Fekete, Szabolcs ^a   Ganzler, Katalin ^a   Fekete, Jenodouble acute ^b  

^a GEDEON RICHTER LTD   (Hungary)

^b BUDAPEST UNIVERSITY OF TECHNOLOGY AND ECONOMICS   (Hungary)

Author keywords

Charged aerosol detection; Detection of non chromophoric excipient; Fast chromatography; Shell particles; Tween 80

Indexed keywords

ACETONITRILE; EXCIPIENT; METHANOL; POLYSORBATE 80; PROTEIN; TRIFLUOROACETIC ACID; WATER;

ANALYTIC METHOD; ARTICLE; CHEMICAL ANALYSIS; CONTROLLED STUDY; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PARTICLE SIZE; PHYSICAL PHASE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REACTION TIME; SENSITIVITY AND SPECIFICITY; SEPARATION TECHNIQUE; SOLVENT EFFECT; SURFACE CHARGE; VALIDATION PROCESS;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; LIMIT OF DETECTION; POLYSORBATES; PROTEINS; SOLUTIONS;

EID: 77950867752     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.02.035     Document Type: Article

References (25)

1. Chawla A.S., Hinberg I., Blais E., Johnson D. Aggregation of insulin, containing surfactants, in contact with different materials. Diabetes 1985, 34:420-424.
2. Lougheed W.D, Albisser A.M., Martindale H.M., Chow J.C., Clement J.R. Physical stability of insulin formulations. Diabetes 1983, 32:424-432.
3. Twardowski Z.J., Nolph K.D., McGray T.J., Moore H.L. Nature of insulin binding to plastic bags. Am. J. Hosp. Pharm. 1983, 40:579-582.
4. USP NF 2006, The United States Pharmacopeia, Twenty-Ninth Revision, National Formulary, Twenty-Fourth Edition, " Polysorbate 80" monograph, " Sorbitan Trioleate" monograph.
5. Ph. Eur., 5.05th edition, " Polysorbate 80" monograph, " Sorbitantrioleate" monograph.
6. Crabb N.T., Persinger H.E. The determination of polyoxyethylene nonionic surfactants in water at the parts per million level. J. Am. Oil Chem. Soc. 1964, 41:752-755.
7. Greff R.A., Setzkorn E.A., Leslie W.D. A colorimetric method for the determination of parts/million of nonionic surfactants. J. Am. Oil Chem. Soc. 1965, 42:180-185.
8. Nozawa A., Ohnuma T., Tatsuya S. Re-examination of the microanalysis of non-ionic surfactants that contain polyoxyethylene chains by the method involving solvent extraction of the thiocyanatocobaltate(II) complex. Analyst 1976, 101:543-548.
9. Anderson N.H., Girling J. Determination of polyoxyethylene non-ionic surfactants at trace levels. Analyst 1982, 107:836-838.
10. Tani T.H., Moore J.M., Patapoff T.W. Single step method for the accurate concentration determination of Polysorbate 80. J. Chromatogr. A 1997, 786:99-106.
11. Pourreza N., Rastegarzadeh S. Kinetic spectrophotometric determination of Tween 80. Talanta 2004, 62:87-90.
12. Forsatz B., Snow N.H. HPLC with charged aerosol detection for pharmaceutical cleaning validation. LC-GC North Am. 2007, 25:960-968.
13. Dixon R., Peterson D. Development and testing of a detection method for liquid chromatography based on aerosol charging. Anal. Chem. 2002, 74:2930-2937.
14. Medved A., Dorman F., Kaufman S., Pocher A. A new corona-based charger for aerosol particles. J. Aerosol. Sci. 2000, 31:S616-S617.
15. Gamache P.H., McCarthy R., Freeto S., Asa D., Woodcock D.M., Laws K., Cole R. HPLC analysis of non-volatile analytes using charged aerosol detection. LC-GC Eur. 2005, 18:345-354.
16. Horvath C., Preiss B.A., Lipsky S.R. Fast liquid chromatography: an investigation of operating parameters and the separation of nucleotides on pellicular ion exchangers. Anal. Chem. 1967, 39:1422-1428.
17. Horvath C., Lipsky S.R.J. Rapid analysis of ribonucleosides and bases at the picomole level using pellicular cation exchange resin in narrow bore columns. Anal. Chem. 1969, 41:1227-1234.
18. Kirkland J.J. Controlled surface porosity supports for high speed gas and liquid chromatography. Anal. Chem. 1969, 41:218-220.
19. Kirkland J.J., Truszkowski F.A., Dilks C.H., Engel G.S. Superficially porous silica microspheres for fast high-performance liquid chromatography of macromolecules. J. Chromatogr. A 2000, 890:3-13.
20. Gritti F., Cavazzinin A., Marchetti N., Guiochon G. Comparison between the efficiencies of columns packed with fully and partially porous C18-bonded silica materials. J. Chromatogr. A 2007, 1157:289-303.
21. Marchetti N., Guiochon G. High peak capacity separations of peptides in reversed-phase gradient elution liquid chromatography on columns packed with porous shell particles. J. Chromatogr. A 2007, 1176:206-216.
22. Ricker R.D., Woodward C.B., Forrer K., Permar B.J., Chen W. Options for rapid analysis of peptides and proteins, using wide-pore, superficially porous, high-performance liquid chromatography particles with unique bonded-phase ligands. J. Chromatogr. Sci. 2008, 46:261-268.
23. ICH Harmonised Tripartite Guideline, Q2A, Text on Validation of Analytical Procedures, October 27, 1994.
24. ICH Harmonised Tripartite Guideline, Impurities In New Drug Products, Q3B(R2) Current Step 4 version dated 2 June 2006.
25. Shabir G.A. Validation of high-performance liquid chromatography methods for pharmaceutical analysis: understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. J. Chromatogr. A 2003, 987:57-66.