Forced Degradation Studies of Drospirenone: Isolation and Characterization of Degradation Products

Aim and Objectives: To remain safe for further processing or human consumption, study of stressed degradation for the identification of feasible degradants is required. The stability indicating high performance thin layer chromatographic method was developed with Camag HPTLC system. Materials and Methods: Silica C60F(254) precoated TLC plates were used as stationary phase for separation of degradation products. The optimized mobile phase system consist of toluene: methanol: diethylamine (7:3:0.1) at 280 nm. Results: From the mass details and IR, NMR interpretation, the plausible structure of alkaline degradation product of drospirenone could be 17 alpha (3-hydroxy propyl)-6 beta, 7 beta, 15 beta, 16 beta-dimethylene-5 beta-androstane-3 beta,5,17 beta triol and acidic degradation product of drospirenone could be 3-oxo-15 alpha,16 alpha-dihydro-3'H-cyclopropa[15,16]-17 alpha-pregna-4,6-diene-21,17-carbolactone. Also in silico toxicity studies of the degradation products were performed to assess the toxicity profile of the products using Protox online sever. Conclusion: This analytical method can be considered as an alternative practical and inexpensive method for simple, accurate and efficient quantitative detection of drospirenone in the presence of its degraded products.

Automated summary

The study identified degradation products of drospirenone and developed a high performance thin layer chromatographic method for accurate detection, as well as conducting toxicity assessment of the degradation products.