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Original Article

J App Pharm Sci. 2021; 11(10): 106-112


New validated Reverse Phase Ultra Performance Liquid Chromatography method for drospirenone and estetrol in Active Pharmaceutical Ingredient and tablet form and its stress studies

Rafi Syed, Rambabu Kantipudi.


Abstract

The UPLC technique we have developed is completely unique and reliable and can quantitatively measure drospirenone and estetrol (E4) simultaneously. The chromatographic column of Luna C18 (100 × 2.6 mm, 1.6 µ) and isocratic elution, with a buffer (0.1% formic acid) and acetonitrile (30:70 v/v), using a flow of 1 ml/minutes at room temperature was used. The process was monitored by ultraviolet detection at 262 nm. A total of 3 minutes was dedicated to using a 3-minute timer to separate drospirenone and E4. Within the concentration range from 3 to 45 µg/ml of drospirenone and 14.2–213 µg/ml of E4, the analysis was completed in less than 5 minutes. System suitability parameters were studied and the outcomes were within acceptable limits when they were injected with the standard six times. To confirm the safety of the formulated product, a market-bought solution was assayed and it was found to be within specification. With all conditions and the acceptable range allowed, degradation studies were carried out on drospirenone and E4, all of which came back with a purity threshold that was higher than the purity angle. This particular technique was found to be consistent with the guidelines set forth by the International Council on Harmonization.

Key words: UPLC, Drospirenone, Estetrol, Development, Validation






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