Liquid paraffin as new dilution medium for the analysis of high boiling point residual solvents with static headspace-gas chromatography

Journal of Pharmaceutical and Biomedical Analysis

Volumn 55, Issue 5, 2011, Pages 1017-1023

  D'Autry, Ward ^a   Zheng, Chao ^a   Bugalama, John ^a   Wolfs, Kris ^a   Hoogmartens, Jos ^a   Adams, Erwin ^a   Wang, Bochu ^a   Van Schepdael, Ann ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

Dilution media; Gas chromatography; Residual solvents; Static headspace; Validation

Indexed keywords

DIMETHYL SULFOXIDE; LIQUID PARAFFIN; ORGANIC COMPOUND; SOLVENT; VOLATILE AGENT;

ANALYTIC METHOD; ARTICLE; CONTROLLED STUDY; DILUTION; GAS CHROMATOGRAPHY; INSTRUMENT; LIMIT OF QUANTITATION; MEDICAL LITERATURE; PRIORITY JOURNAL; SAMPLE; TEMPERATURE; VAPOR PRESSURE;

CHEMISTRY TECHNIQUES, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GAS; MINERAL OIL; ORGANIC CHEMICALS; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; SOLVENTS; TEMPERATURE; VOLATILIZATION;

EID: 79956132401     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.04.004     Document Type: Article

References (21)

1. Witschi C., Doelker E. Residual solvents in pharmaceutical products: acceptable limits, influences on physicochemical properties, analytical methods and documented values. Eur. J. Pharm. Biopharm. 1997, 43:215-242.
2. Q3C(R4) Impurities: Guidelines for Residual Solvents, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, 2009.
3. Identification and Control of Residual Solvents (2.4.24.), European Pharmacopoeia 2010, European Department for the Quality of Medicines, Strasbourg. 6th ed.
4. Kolb B., Ettre L.S. Static Headspace-Gas Chromatography: Theory and Practice 1997, Wiley-VCH, Weinheim. 2nd ed.
5. B'Hymer C. Residual solvent testing: a review of gas-chromatographic and alternative techniques. Pharm. Res. 2003, 20:337-344.
6. Camarasu C.C. Residual solvents determination in drug products by static headspace-gas chromatography. Chromatographia 2002, 56:S137-S143.
7. Iosefzon-Kuyavskaya B. Quality control in residual solvent analysis: the static headspace gas chromatographic method. Accredit. Qual. Assur. 1999, 4:240-246.
8. Kumar N., Gow J.G. Residual solvent analysis by headspace gas chromatography. J. Chromatogr. A 1994, 667:235-240.
9. Camarasu C.C. Headspace SPME method development for the analysis of volatile polar residual solvents by GC-MS. J. Pharm. Biomed. Anal. 2000, 23:197-210.
10. Coran S.A., Giannellini V., Furlanetto S., Bambagiotti-Alberti M., Pinzauti S. Improving gas chromatographic determination of residual solvents in pharmaceuticals by the combined use of headspace solid-phase microextraction and isotopic dilution. J. Chromatogr. A 2001, 915:209-216.
11. Wang X., Jiang T., Yuan J.P., Cheng C.G., Liu J.H., Shi J.B., Zhao R.S. Determination of volatile residual solvents in pharmaceutical products by headspace liquid-phase microextraction gas chromatography-flame ionization detector. Anal. Bioanal. Chem. 2006, 385:1082-1086.
12. Hashimoto K., Urakami K., Fujiwara Y., Terada S., Watanabe C. Determination of residual solvents in pharmaceuticals by thermal desorption-GC/MS. Anal. Sci. 2001, 17:645-648.
13. Lakatos M. Measurement of residual solvents in a drug substance by a purge-and-trap method. J. Pharm. Biomed. Anal. 2008, 47:954-957.
14. David F., Szucs R., Makwana J., Sandra P. Fast capillary GC using a low thermal mass column oven for the determination of residual solvents in pharmaceuticals. J. Sep. Sci. 2006, 29:695-698.
15. Pavon J.L.P., Sanchez M.D., Laespada M.E.F., Pinto C.G., Cordero B.M. Analysis of class 1 residual solvents in pharmaceuticals using headspace-programmed temperature vaporization-fast gas chromatography-mass spectrometry. J. Chromatogr. A 2007, 1141:123-130.
16. Crimi C.M., Snow N.H. Analysis of pharmaceutical residual solvents using comprehensive two-dimensional gas chromatography. LC-GC North Am. 2008, 26:62-70.
17. Urakami K., Higashi A., Umemoto K., Godo M. Matrix media selection for the determination of residual solvents in pharmaceuticals by static headspace gas chromatography. J. Chromatogr. A 2004, 1057:203-210.
18. Laus G., Andre M., Bentivoglio G., Schottenberger H. Ionic liquids as superior solvents for headspace gas chromatography of residual solvents with very low vapor pressure, relevant for pharmaceutical final dosage forms. J. Chromatogr. A 2009, 1216:6020-6023.
19. Liu F.H., Jiang Y. Room temperature ionic liquid as matrix medium for the determination of residual solvents in pharmaceuticals by static headspace gas chromatography. J. Chromatogr. A 2007, 1167:116-119.
20. Von Wald G., Albers D., Cortes H., McCabe T. Background vapor from six ionic liquids and the partition coefficients and limits of detection for 10 different analytes in those ionic liquids measured using headspace gas chromatography. J. Chromatogr. A 2008, 1201:15-20.
21. Snow N.H., Bullock G.P. Novel techniques for enhancing sensitivity in static headspace extraction-gas chromatography. J. Chromatogr. A 2010, 1217:2726-2735.