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Development and validation of reversed-phase-HPLC method for simultaneous quantification of fulvestrant and
Hamdi Nsairat1, Walhan Alshaer2, Zainab Lafi1
1Pharmacological & Diagnostic Research Center, Al-Ahliyya Amman University, Amman, 19328, Jordan.
Abstract:
This study aims to develop and validate an HPLC technique for the determination of fulvestrant and disulfiram in liposomes. Encapsulation of both drugs into liposomes may improve their anticancer potential. Validation was performed following the International Conference on Harmonization guidelines for specificity, linearity, limit of detection, limit of quantification, precision, accuracy and robustness. Method specificity displayed no interference and linearity over 25-200 and 12.5-100 μg/ml for fulvestrant and disulfiram, respectively. Precision and accuracy exhibited a low relative standard deviation (<1.70%) and appropriate recovery. The validated method could be designated as a proper method for the simultaneous determination of fulvestrant and disulfiram in liposomes. The liposomes displayed 148.5 ± 5.1 nm size. The encapsulation efficiencies were 73.52 and 50.50% for fulvestrant and disulfiram, respectively.
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