A Novel Technique For The Simultaneous Analysis Of Drosperinone And Estetrol In Bulk And Tablet Dosage Form By Rp- Uplc

Abstract

A convenient, precise, consistent, and robust quantitative approach was established for separation and simultaneous quantification of drosperinone and estetrol in bulk and tablet dosage form. The chromatographic separation was carried out by using CSH C18( 50x 2.1mm, 1.7 ) column at a temperature of 30°C and by using isocratic separation mode with a flow rate of 0.3ml/min. The system was operated by using mobile phase 0.01N kh2po4 buffer and acetonitrile(60:40v/v) with a TUV detector at a detection wavelength of 240nm. Drosperinone and Estetrol retention time was found to be 1.87min and 1.46min respectively. The recommended method was validated for linearity, accuracy, precision, robustness as per the ICH guidelines and the method found to be acceptable. The stress degradation studies were developed and found to be satisfactory. Results shows that the proposed method was precise, simple, robust and suitable for routine analysis.