Development and validation of a stability-indicating RP-LC method for the determination of anticancer drug epirubicin in pharmaceuticals


KURBANOĞLU S., Palabiyik B. B., GÜMÜŞTAŞ M., Şanl S., USLU B., ÖZKAN S. A.

Journal of Liquid Chromatography and Related Technologies, cilt.37, sa.11, ss.1583-1596, 2014 (SCI-Expanded) identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 37 Sayı: 11
  • Basım Tarihi: 2014
  • Doi Numarası: 10.1080/10826076.2013.803202
  • Dergi Adı: Journal of Liquid Chromatography and Related Technologies
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.1583-1596
  • Anahtar Kelimeler: epirubicin, liquid chromatography, stability-indicating high-performance, validation
  • Uşak Üniversitesi Adresli: Evet

Özet

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 × 4.6mm × 5mm) using acetonitrile/water (30:70 v/v) mixture containing 15 mM phosphoric acid as mobile phase at 0.6 mL 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°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. © 2014 Copyright Taylor & Francis Group, LLC.