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. 2016 Jun;6(2):251-6.
doi: 10.15171/apb.2016.034. Epub 2016 Jun 30.

A Simple, Fast, Low Cost, HPLC/UV Validated Method for Determination of Flutamide: Application to Protein Binding Studies

Sara Esmaeilzadeh  1 , Hadi Valizadeh  2 , Parvin Zakeri-Milani  3
Affiliations

A Simple, Fast, Low Cost, HPLC/UV Validated Method for Determination of Flutamide: Application to Protein Binding Studies

Sara Esmaeilzadeh et al. Adv Pharm Bull. 2016 Jun.

Abstract

Purpose: The main goal of this study was development of a reverse phase high performance liquid chromatography (RP-HPLC) method for flutamide quantitation which is applicable to protein binding studies.

Methods: Ultrafilteration method was used for protein binding study of flutamide. For sample analysis, flutamide was extracted by a simple and low cost extraction method using diethyl ether and then was determined by HPLC/UV. Acetanilide was used as an internal standard. The chromatographic system consisted of a reversed-phase C8 column with C8 pre-column, and the mobile phase of a mixture of 29% (v/v) methanol, 38% (v/v) acetonitrile and 33% (v/v) potassium dihydrogen phosphate buffer (50 mM) with pH adjusted to 3.2.

Results: Acetanilide and flutamide were eluted at 1.8 and 2.9 min, respectively. The linearity of method was confirmed in the range of 62.5-16000 ng/ml (r(2) > 0.99). The limit of quantification was shown to be 62.5 ng/ml. Precision and accuracy ranges found to be (0.2-1.4%, 90-105%) and (0.2-5.3 %, 86.7-98.5 %) respectively. Acetanilide and flutamide capacity factor values of 1.35 and 2.87, tailing factor values of 1.24 and 1.07 and resolution values of 1.8 and 3.22 were obtained in accordance with ICH guidelines.

Conclusion: Based on the obtained results a rapid, precise, accurate, sensitive and cost-effective analysis procedure was proposed for quantitative determination of flutamide.

Keywords: Acetanilide; Flutamide; High pressure liquid chromatography; ICH guidelines; Protein binding.

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References

    1. Schulz M, Schmoldt A, Donn F, Becker H. The pharmacokinetics of flutamide and its major metabolites after a single oral dose and during chronic treatment. Eur J Clin Pharmacol. 1988;34(6):633–6. doi: 10.1007/bf00615229. - DOI - PubMed
    1. Álvarez-Lueje A, Peña C, Núñez-Vergara LJ, Squella JA. Electrochemical Study of Flutamide, an Anticancer Drug, and Its Polarographic, UV Spectrophotometric and HPLC Determination in Tablets. Electroanal. 1998;10(15):1043–51.
    1. Wood AJ, Robertson D, Robertson RM, Wilkinson GR, Wood M. Elevated plasma free drug concentrations of propranolol and diazepam during cardiac catheterization. Circulation. 1980;62(5):1119–22. doi: 10.1161/01.cir.62.5.1119. - DOI - PubMed
    1. Zeitlinger MA, Derendorf H, Mouton JW, Cars O, Craig WA, Andes D. et al. Protein Binding: Do We Ever Learn? Antimicrob Agents Chemother. 2011;55(7):3067–74. doi: 10.1128/aac.01433-10. - DOI - PMC - PubMed
    1. Shet MS, McPhaul M, Fisher CW, Stallings NR, Estabrook RW. Metabolism of the antiandrogenic drug (Flutamide) by human CYP1A2. Drug Metab Dispos. 1997;25(11):1298–303. - PubMed