Separation of positional isomers of mono-poly(ethylene glycol)-modified octreotides by reversed-phase high-performance liquid chromatography

J Chromatogr A. 2009 Nov 6;1216(45):7793-7. doi: 10.1016/j.chroma.2009.09.023. Epub 2009 Sep 12.

Abstract

The purpose of this study was to develop a reversed-phase high-performance liquid chromatographic method (RP-HPLC) for separating each positional isomer from low- to high-molecular-weight mono-PEGylated octreotides prepared by polyethylene glycol (PEG) derivatives with various molecular weights (2, 5, or 20kDa). In the gradient elution using acetonitrile and 10mM phosphate buffer at pH 7.0 on a Phenomenex Gemini C-18 column (250mmx4.6mm id, 5microm), each positional isomer of the mono-PEGylated octreotides was completely resolved with good resolution (PEG-2K: 7.6, PEG-5K: 6.6, and PEG-20K: 3.1). The optimal RP-HPLC condition also resolved the degradation products of mono-PEG-octreotide isomers in thermal stability studies at 55 degrees C and enzymatic stability studies with trypsin. In conclusion, the developed RP-HPLC method will be valuable for studying the effect of PEGylation site and the attached PEG size on the physicochemical and pharmacological properties of PEGylated octreotides.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chromatography, Reverse-Phase / methods*
  • Isomerism
  • Molecular Weight
  • Octreotide / chemistry*
  • Octreotide / isolation & purification*
  • Polyethylene Glycols / chemistry*

Substances

  • Polyethylene Glycols
  • Octreotide