Stability indicating RP-HPLC method for simultaneous estimation of estetrol and drospirenone in bulk and pharmaceutical dosage forms

A straightforward, quick, accurate, sensitive, and repeatable reverse phase high performance liquid chromatography (RP-HPLC) approach has been devised to analyze estetrol and Drospirenone in pharmaceutical dose form quantitatively. Estetrol and Drospirenone were separated chromatographically on a Waters Alliance-e2695 using a Waters X-Terra RP-18 (250x4.6mm, 5μ) column and a mobile phase that contained 0.1% perchloric acid and acetonitrile in a 30:70% v/v ratio. The absorption at 265 nm was detected using a photodiode array detector operating at room temperature, with a flow rate of 1.0 ml/min. The tailing factor should not exceed two for Drospirenone and Estetrol, and the number of theoretical plates was NLT 2000, respectively. All measurements have a relative standard deviation of peak areas consistently smaller than 2.0. In compliance with ICH guidelines, the suggested approach was validated. The approach was determined to be straightforward, cost-effective, appropriate, accurate, precise, and reliable for the quantitative analysis of estetrol and the stability research of Drospirenone.