Validation of an HPTLC method for impurities testing and determination of the logP value of a new phospholipid

Journal of Planar Chromatography - Modern TLC

Volumn 10, Issue 4, 1997, Pages 290-297

  Rischer, Matthias ^a   Schnell, Horst ^a   Greguletz, Roland ^a   Wolf Heuss, Elisabeth ^a   Engel, Jürgen ^a  

^a ASTA MEDICA AG   (Germany)

Author keywords

HPTLC; ICH; Impurities testing; LogP; Phospholipids; Validation

Indexed keywords

PERIFOSINE; PHOSPHOLIPID; UNCLASSIFIED DRUG;

ACCURACY; CONFERENCE PAPER; DRUG CONTROL; DRUG DETERMINATION; DRUG IMPURITY; HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY; TECHNIQUE;

EID: 0030845952     PISSN: 09334173     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (14)

1. J. Stekar, G. Nösner, B. Kutscher, J. Engel, and P. Hilgard, Angew. Chem. 107(2) (1995) 195-197.
2. I. Rustenbeck and S. Lenzen, J. Chromatogr. Biomed. Appl. 90(1) (1990) 85-91.
3. I. Rustenbeck, A. Tremner, and S. Lenzen, J. Planar Chromatogr. 2(3) (1989) 207-210;
4. L. Kovacs, J. Pucsok, A. Zarka, R. Dobo, and I. Gyroc, Fett. Wiss. Technol. 90(5) (1988) 195-199.
5. S. Kromidas, R. Klinkner, and R. Mertens, Nachr. Chem. Tech. Lab. 43 (1995) 669-676.
6. B. Renger, H. Jehle, M. Fischer, and W. Funk, Pharm. Ind. 56(11) (1994) 993-1000.
7. R. Greguletz "Diplomarbeit" Untersuchung zur Verteilung von Alkylphospholipiden im System Octanol/Wasser.
8. Note for Guidance on Impurities in New Drug Substances (CPMP 142/95), which is based on ICH requirements.
9. M. Rischer, I. Behr, E. Wolf-Heuss, and J. Engel, J. Planar Chromatogr. 8(5) (1995) 382-387.
10. ICH Draft Guideline on the Validation of Analytical Methodology, Federal Register Notice, March 7, 1996. Note for guidance on validation of analytical procedures: Methodology (CPMP/ICH/281/95), December 18, 1996.
11. T. Hiroshi, Quant. Struct.-Act. Relat. 5 (1986) 81-88.
12. Pon Hsiung Wang and E.J. Lien, J. Pharm. Sci. 69(6) (1984) 662-667.
13. J.E. Garst and W.C. Wilson, J. Pharm. Sci. 73(11) (1984) 1616-1623.
14. G.L. Biagi, J. Chromatogr. 498 (1990) 179-190.