DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-LC METHOD FOR THE DETERMINATION OF ANTICANCER DRUG EPIRUBICIN IN PHARMACEUTICALS

Kurbanoğlu S., Bozal Palabıyık B., Gümüştaş M., Şanlı S., Uslu B., Özkan S. A.

JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, vol.37, no.11, pp.1583-1596, 2014 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 37 Issue: 11
  • Publication Date: 2014
  • Doi Number: 10.1080/10826076.2013.803202
  • Journal Name: JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.1583-1596
  • Keywords: epirubicin, pKa determination, validation, liquid chromatography, stability-indicating high-performance, PERFORMANCE LIQUID-CHROMATOGRAPHY, TANDEM MASS-SPECTROMETRY, SOLVENT COMPOSITION, POLYPHENOLIC ACIDS, MODELING RETENTION, ORGANIC-SOLVENTS, PH MEASUREMENTS, HUMAN PLASMA, HUMAN SERUM, ANTHRACYCLINES
  • Ankara University Affiliated: Yes

Abstract

In the present paper, sensitive, rapid, and different analytical methodology was developed for the determination of anticancer drug epirubicin (EPR). The mixture of epirubicin and moxifloxacin as internal standard was separated on a reversed phase Waters Spherisorb ODS1 column (250mm x 4.6mm x 5mm) using acetonitrile/water (30:70v/v) mixture containing 15mM phosphoric acid as mobile phase at 0.6mL min(-1) flow rate and 30 C. Also degradation studies were conducted as stress conditions of UV light, acidic hydrolysis, alkaline hydrolysis, oxidation, and heat in oven (100 degrees C), to evaluate the ability of the proposed method for the separation of EPR from its degradation products. The validated method suggests routine analysis of EPR in differently equipped laboratories.