title: Stability Indicating HPLC Method for the Determination of Fulvestrant in Pharmaceutical Formulation in Comparison with Linear Sweep Voltammetric Method.
abstract: 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-1for LSV and 0.5-20 m g mL-1for 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-1for 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.
authors.affiliation: Department of Analytical Chemistry, Faculty of Pharmacy, Ataturk University, 25240, Erzurum, Turkey.
authors.forename: Alptug
authors.initials: A
authors.lastname: Atila
authors.affiliation: Department of Analytical Chemistry, Faculty of Pharmacy, Ataturk University, 25240, Erzurum, Turkey.
authors.forename: Bilal
authors.initials: B
authors.lastname: Yilmaz
authors.affiliation: Department of Analytical Chemistry, Faculty of Pharmacy, Ataturk University, 25240, Erzurum, Turkey.
authors.forename: Yucel
authors.initials: Y
authors.lastname: Kadioglu
keywords: Fulvestrant; HPLC; LSV; Stability indicating; Validation