Validated RP-HPLC method for the simultaneous analysis of gemcitabine and LY-364947 in liposomal formulations

Shyam S. Bansal, Christian Celia, Silvia Ferrati, Erika Zabre, Mauro Ferrari, Ganesh Palapattu, Alessandro Grattoni

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

Combined use of gemcitabine (Gem) and LY-364947 (LY), a TGF-β1 receptor inhibitor, has shown promise for the treatment of fibrotic pancreatic cancer, by reducing collagen production and improving tumor drug penetration. The preparation and optimization of novel Gem and LY formulations, including co-encapsulation in liposomes, require a validated method for the simultaneous quantification of both drugs, a method that had yet to be developed. Here we demonstrate an RP-HPLC protocol for the simultaneous detection of Gem and LY at 266 and 228 nm with retention times of 3.37 and 11.34 mins, respectively. The method, which uses a C18 column and a KH2PO4 (10 mM)-methanol mobile phase, was validated for linearity, precision, accuracy, limits of detection, and robustness. Co-loaded liposomes with both Gem and LY (Gem/LY liposomes) were developed to investigate the protocol applicability to pharmacokinetic analysis and formulation characterization. The method specificity was evaluated in presence of liposomal components in fetal bovine serum (FBS). Finally, the method was demonstrated by quantifying Gem/LY liposomal encapsulation efficiency and concentration liposomes-spiked FBS.

Original languageEnglish (US)
Pages (from-to)1061-1069
Number of pages9
JournalCurrent Drug Targets
Volume14
Issue number9
DOIs
StatePublished - Aug 15 2013

Keywords

  • Chemotherapeutics
  • Gemcitabine
  • Liposomes
  • LY-364947
  • RP-HPLC
  • Simultaneous analysis

ASJC Scopus subject areas

  • Drug Discovery
  • Pharmacology
  • Clinical Biochemistry
  • Molecular Medicine

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