Stability Indicating HPLC Method for the Determination of Fulvestrant in Pharmaceutical Formulation in Comparison with Linear Sweep Voltammetric Method


ATİLA A., YILMAZ B., KADIOĞLU Y.

IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH, cilt.15, sa.3, ss.369-378, 2016 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 15 Sayı: 3
  • Basım Tarihi: 2016
  • Dergi Adı: IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.369-378
  • Atatürk Üniversitesi Adresli: Evet

Özet

This paper describes two rapid, sensitive and specific methods for the determination of fulvestrant in pharmaceutical preparations by high performance liquid chromatography (HPLC) and linear sweep voltammetry (LSV). HPLC method was used to study the degradation behaviour. Fulvestrant was subjected to degradation under the conditions of hydrolysis (acid and alkali), oxidation (30% H2O2). The linearity was established over the concentration range of 5-50 m g mL(-1) for LSV and 0.5-20 m g mL(-1) for HPLC method. The intra-and inter-day relative standard deviation (RSD) was less than 3.96 and 3.07% for LSV and HPLC, respectively. Limits of quantification were determined as 5.0 and 0.50 m g mL(-1) for LSV and HPLC, respectively. No interference was found from tablet excipients at the selected assay conditions. The methods were applied for the quality control of commercial fulvestrant dosage form to quantify the drug and to check the formulation content uniformity.