Simultaneous determination of ethinyl estradiol and drospirenone in oral contraceptive by high performance liquid chromatography

Author:

Silva Viviane Benevenuti1,Galdos Angel Arturo Gaona1,Mothe Cintia Maria Alves1,Pallastrelli Michele Bacchi1,Prado Maria Segunda Aurora1,Singh Anil Kumar1,Kedor-Hackmann Erika Rosa Maria1,Santoro Maria Inês Rocha Miritello1

Affiliation:

1. University of São Paulo, Brazil

Abstract

A simple, rapid, economical and reliable high performance liquid chromatographic method has been developed and successfully applied in simultaneous determination of ethinyl estradiol and drospirenone in coated tablets. The HPLC method was performed on a LiChroCART® 100RP column (125x4 mm i.d., 5 µm) with acetonitrile:water 50:50 (v/v) as mobile phase, pumped at a flow rate of 1.0 mL.min-1. The fluorescence detection for ethinyl estradiol was made at λex= 280 nm and λem= 310 nm and a UV detection for drospirenone was made at 200 nm. The elution time for ethinyl estradiol and drospirenone were 4.0 and 5.7 min, respectively. The method was validated in accordance to USP 34 guidelines. The proposed HPLC method presented advantages over reported methods and is suitable for quality control assays of ethinyl estradiol and drospirenone in coated tablets.

Publisher

FapUNIFESP (SciELO)

Subject

General Pharmacology, Toxicology and Pharmaceutics

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