STRUCTURE ELUCIDATION OF OXIDATIVE DEGRADATION PRODUCT OF DROSPIRENONE

Stressed degradation study of Drospirenone in H₂O₂ and characterization of degradants by IR, NMR, LC-MS was done. Stressed degradation study of Drospirenone in H₂O₂ and characterization of degradants by IR, NMR, and LC-MS was done. To evaluate the stability of Drospirenone under stress conditions, it was subjected to oxidative degradation, according to ICH guideline Q1A (R2). The analysis was carried out on C18 Thermo Hypersil BDS (250 × 4.6 × 5 mm) column, using ammonium acetate: acetonitrile (70:30) pH 6.8 as mobile phase with flow rate 1ml/min and analysis was done using PDA detector at an ambient temperature where 3.15 min was retention time of the drug. The Linearity, precision, and accuracy were found to be satisfactory over the concentration range of 10 to 60 µg/ml of the drug. The correlation coefficient was 0.987. Drospirenone was found to degrade in 1% H₂O₂ to the extent of 19% after 1 h. More degradation was observed by using 3% H₂O₂ at 80 ºC. Interestingly, in the applied conditions, the new compound was found out in a significant amount with oxidative stress conditions. FT-IR, NMR, LC-MS data demonstrated that the oxidative stressed impurity of Drospirenone (Biphenyl moiety) is reported. The method was effectively applied to the determination of Drospirenone with decomposed products in quality control laboratories.