Validated High Performance Liquid Chromatography Method for the Determination of Fulvestrant in Pharmaceutical Dosage Forms

Author(s): Murali Balaram Varanasi, Mushraff Ali Khan, Venkateswara Rao Jangala, Bulusu Bhanu Teja and Srikanth Allamraju

A simple and rapid normal phase high performance liquid chromatography (HPLC) method was developed and validated for quantitative determination of fulvestrant in bulk drug samples and formulations. Fulvestrant was analyzed by using normal phase cyano column (4.6 mm x 25 cm, 5 µm) at ambient temperature, with gradient elution of n-hexane and isopropyl alcohol as a mobile phase (70 : 30 v/v). The flow rate was set 1.5 mL/min and the analysis was performed at a wavelength of 220 nm using Photo Diode Array (PDA) detector. Two peaks were obtained (FST-A and FST-B) for the corresponding enantiomers. The retention time (RT) for FST- A was around 30.5 ± 1 minutes and retention time for FSTB was 30.0 ± 1 min. The calibration curves were linear over a concentration range from 2.5 mg to 7.5 mg/mL. Limit of detection (LOD) for FST-A was 0.0011 mg/mL and LOD for FST-B was 0.0010 mg/mL. Limit of quantitation (LOQ) FST-A was 0.0033 mg/mL and for FST-B was 0.0030 mg/mL respectively. The developed method was successfully applied to estimate the amount of fulvestrant in formulations.

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