VALIDATED STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ESTETROL AND DROSPIRENONE

Abstract

The prescription dose form of Estetrol and Drospirenone may be accurately and precisely measured using a new, easy-to-use technology. Chromatograms were produced using a standard Agilent C18 150 x 4.6 mm, 5m column. A mobile phase consisting of a 50:50 mixture of Buffe0.1N KH2PO4 and acetonitrile was passed down the column at a rate of 1 ml/min. The KH2PO4 buffer was used in this procedure. The temperature was kept at 30 degrees Celsius. The 263 nm wavelength was chosen as the optimal one. Estetrol had a %RSD of 0.5 and Drospirenone a %RSD of 0.8, while their retention times were 2.268 and 2.698 minutes, respectively. %Estetrol had a recovery of 100.91% and Drospirenone 99.76%. Estetrol's LOD was 0.39, Drospirenone's LOQ was 1.18, and the two chemicals' regression equations yielded LOQ and LOD values of 0.01 and 0.03, respectively. The Estetrol regression equation is y = 26009x + 3120.7, whereas the Drospirenone regression equation is y = 25028x + 719.64. The new approach was easy and affordable, allowing it to be implemented for routine quality control tests in industries. It lowered retention times and run time.