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

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 λ ex = 280 nm and λ em = 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. Um método simples, rápido, econômico e confiável foi desenvolvido empregando a cromatografia líquida de alta eficiência para a determinação simultânea de etinilestradiol e drospirenona em comprimidos revestidos. O método foi realizado utilizando coluna LiChroCART ® 100RP (125 x 4 mm d.i., 5 µm), a fase móvel constituída de acetonitrila:água, 50:50 (v/v) com vazão de 1,0 mL.min -1 . A detecção foi realizada empregando fluorescência em λ ex = 280 nm e λ em = 310 nm para o etinilestradiol e na região de UV em 200 nm para a drospirenona. O etinilestradiol e a drospirenona tiveram tempo de retenção de 4,0 e 5,7 min, respectivamente. O método foi validado de acordo com as diretrizes da USP 34. O método proposto apresentou vantagens sobre os relatados na literatura e pode ser considerado adequado para o controle de qualidade do etinilestradiol e da drospirenona em comprimidos revestidos. Unitermos:Comprimidos revestidos/análise quantitativa. Cromatografia líquida de alta eficiência/ análise quantitativa. Etinilestradiol/determinação quantitativa. Drospirenona/determinação quantitativa. Detecção por fluorescência. Detecção no UV.

Development of Simultaneous Derivative Spectrophotometric and HPLC Methods for Determination of 17-Beta-Estradiol and Drospirenone in Combined Dosage Form

“…Both methods are cost effective compared to the LC-MS methods. Considering the linearity values and LOD values of DRS, the both proposed methods were more sensitive than reported RP-HPLC methods for the assay of the drug alone [ 5 ] and in combination with ethynyl estradiol in pharmaceutical preparations [ 3 , 4 ]. The proposed methods for the determination of ESR were found to be more sensitive than some of the published HPLC-UV methods [ 16 , 22 , 33 ].…”

“…So far, some high performance liquid chromatograph (HPLC) techniques coupled with ultraviolet (UV) [ 3 – 5 ], radioimmunoassay (RIA) [ 1 , 2 ], and tandem mass spectrometry (MS/MS) methods [ 6 , 7 ] have been published for quantification and pharmacokinetic studies of drospirenone alone and in combination with drugs in pharmaceutical formulations [ 4 – 6 ] and biological fluids [ 1 , 2 , 6 , 7 ].…”

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“…The literature on the analytical methods used for the estimation of Drospirenone suggests that most widely high-performance liquid chromatography (HPLC) techniques have been published for quantification and pharmacokinetic studies of Drospirenone mostly in combination with ethinyl estradiol or other drugs in pharmaceutical formulations and biological fluids [6][7][8][9][10][11][12][13] . In the present study, attempts were made to develop a simple, accurate, and precise method for estimation of Drospirenone in the presence of its oxidative degradation products.…”

Norelgestromin/ethinyl estradiol intravenous infusion formulation optimization, stability and compatibility testing: A case study to overcome polysorbate 80 interference in chromatographic analysis

“…Norelgestromin/ethinyl estradiol is a progestin/estrogen combination hormonal contraceptive indicated for the prevention of pregnancy in women [1,2]. Ethinyl estradiol (EE), 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17 ␣), is a synthetic derivative of natural estrogen estradiol, having high estrogen receptor potency and used for treatment of vasomotor symptoms associated with menopause, female hypogonadism, prostatic carcinoma-palliative therapy, breast cancer, and oral and emergency contraception [3,4].…”

“…Most of the published HPLC methods were for the quantification of ethinyl estradiol either with other estradiol degradation products [16] levonorgestrel [4,[17][18][19], desogestrel [20], or drospirenone [2,3,21]. Also, none of the published methods discussed the difficulty in analyzing these hormones in the presence of polysorbate 80 with its significant spectroscopic and chromatographic interference.…”