Author/Authors :
Atil, Alptug Department of Analytical Chemistry, Faculty of Pharmacy, Ataturk University, 25240, Erzurum, Turkey , Yilmaz, Bilal Department of Analytical Chemistry, Faculty of Pharmacy, Ataturk University, 25240, Erzurum, Turkey , Kadioglu, Yucel Department of Analytical Chemistry, Faculty of Pharmacy, Ataturk University, 25240, Erzurum, Turkey
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-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
Keywords :
Fulvestrant , LSV , HPLC , Stability indicating , Validation
