New protamine quantification method in microtiter plates using o-phthaldialdehyde/N-acetyl-L-cysteine reagent

Int J Pharm. 2004 Sep 28;283(1-2):11-7. doi: 10.1016/j.ijpharm.2004.05.032.

Abstract

Protamine is a well-known excipient in pharmaceutics. It represents a peptide consisting of exclusive aliphatic amino acids, hence it cannot be quantified by UV-spectroscopy (lambdamax 280 nm). A new and sensitive quantification method based on the derivatisation of protamine with ortho-phthaldialdehyde (OPA) in the presents of 2-mercaptoethanol (ME) or N-acetyl-L-cysteine (NAC) in basic aqueous solution using 96-well microtiter plates are introduced in this report. The resulting isoindol derivatives reveal a fluorescence excitation (maximum lambdaex 345 nm) and emission (maximum lambdaem 450 nm) spectra. Derivatives of OPA/NAC reagent were found to be useful for protamine quantification in pharmaceutical nanoparticle preparation containing DNA. A sufficient stability of the isoindol derivatives was shown. It was possible to determine protamine free base, protamine sulphate and protamine chloride with limits of detection less than 1.1 microg/ml.

MeSH terms

  • Acetylcysteine
  • Heparin Antagonists / chemistry*
  • Indicators and Reagents
  • Protamines / chemistry*
  • Technology, Pharmaceutical*
  • o-Phthalaldehyde

Substances

  • Heparin Antagonists
  • Indicators and Reagents
  • Protamines
  • o-Phthalaldehyde
  • Acetylcysteine