Determination of Dienogest in Pure Form and Pharmaceutical Preparation by Stability-indicating Spectrophotometric Method

Abstract

The present work describes a highly sensitive stability-indicating UV-spectrometric method for the estimation of dienogest in commercial formulation. A simple, rapid, sensitive, accurate and precise stability-indicating spectrophotometric methods were developed for the determination of dienogest and its degradants in bulk powder and in a pharmaceutical preparation. The methods were validated over a linear range of 1 – 5 \(\mu\)g/mL and successfully applied to the determination of dienogest at 297 nm with an average percent recovery of 93.9 – 100.3. Dienogest was subjected to stress degradation under various ICH-recommended conditions. The samples generated in this manner were used for degradation studies using the developed method. The proposed methods have been validated and can be used to analyse formulations that contain dienogest. A simple, accurate, precise, robust, and rapid UV visible spectrophotometric method for estimating dienogest in pharmaceutical dosage form has been developed and validated in accordance with ICH guidelines.