Abstract

A NEW STABILITY INDICATING METHOD FOR SIMULTANEOUS ESTIMATION OF DROSPIRENONE AND ESTETROL BY USING RP-HPLC METHOD IN ITS BULK AND PHARMACEUTICAL DOSAGE FORM

B. Revathi Rao*, Purama Roshini, Afreen Begum, Chandre Vishal, Khola Sai Charan and Suryavanshi Balaji

ABSTRACT

A simple, accurate, correct, specific process was developed for the simultaneous inference of the Drospirenone & Estetrol in Tablet dosage form. Chromatogram was run during Agilent C18 150 x 4.6 mm, 5. Mobile phase containing buffer Ortho phosphoric acid: Acetonitrile taken in the ratio 55:45 was pumped through column at a flow of 1.0ml/min. Buffer used in this method was OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 240.0 nm. Retention time of Drospirenone and Estetrol were found to be 2.257 min and 2.928. %RSD of the Drospirenone and Estetrol were and found to be 0.6 and 0.6 respectively. %Recovery was obtained as 100.99% and 100.07% for Drospirenone and Estetrol respectively. LOD, LOQ values obtained from regression equations of Drospirenone and Estetrol were 0.01, 0.03 and 0.03, 0.08 respectively. Regression equation of Drospirenone is y = 16939x + 200.32 and y = 18772x + 1427.2 of Estetrol. System suitability parameters were studied and the outcomes were within acceptable limits when they were injected with the standard six times. Degradation studies were performed with the formulation and the degraded samples were injected and all the samples passed the limits of degradation.This particular technique was found to be consistent with the guidelines set forth by the International Council on Harmonization.

Keywords: Drospirenone, Estetrol, Method validation, RP-HPLC, Simultaneous estimation, Stress studies.