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Abstract

Aim: Toxicokinetic and pharmacokinetic studies of therapeutic oligonucleotides require validated bioanalytical methods for sensitive and specific quantification of oligonucleotide drug candidates in biological samples. Results: A peptide nucleic acid (PNA) hybridization-based HPLC-fluorescence assay was developed and validated for quantification of Arrowhead Pharmaceuticals’ proprietary siRNA in rat plasma samples via hybridization and anion-exchange-HPLC (AEX-HPLC) with fluorescence detection. Conclusion: The validated method provided a sensitive and selective approach for quantification of siRNA in biological samples at a linear quantitation range of 1–1000 ng/ml. The assay requires only 25 μl of plasma sample and shows excellent accuracy and precision even without using an internal standard, providing a useful quantification method for siRNA determination in biological matrix with limited sample volume.

Keywords:

  • AEX-HPLC
  • fluorescence
  • hybridization
  • LLOQ
  • metabolites
  • oligonucleotides
  • PNA
  • siRNA
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