Validated Stability Indicating RP-hplc Method for the Assay of Dienogest in Bulk and Tablet Dosage Form
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A stability-indicating RP-HPLC method was developed and validated for accurately determining dienogest in bulk and tablet forms using a C18 column and an acetonitrile mobile phase.
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Abstract
Dienogest is used for of treatment of endometriosis. A Stability indicating Reversed phase high Performance Liquid Chromatographic method has been developed for the determination of Dienogest in bulk as well as in innovator Product (Visanne Tablets 2mg). Various Critical issues regarding chromatographic conditions are resolved using Thermo Hypersil BDS C18 150 x 4.6mm, 5µm or equivalent column. 40% Acetonitrile is used as Mobile Phase for elution of very distinct Peak for the Dienogest. The developed Method has been validated as Per ICH Q2B to asses the method as simple, Precise, accurate and robust enough to withstand the changes in Method Parameters. The Peak of Dienogest is eluted near the Retention time of 4.5 Minutes
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Cites (2)
- MICRONIZATION: AN EFFICIENT TOOL FOR DISSOLUTIONENHANCEMENT OF DIENOGEST 2011
- Development and Evaluation of Dienogest Vaginal Tablet for Treatment of Endometriosis 2011
Cited by (1)
References (5)
- Development and Evaluation of Dienogest Vaginal Tablet for Treatment of Endometriosis via openalex
- MICRONIZATION: AN EFFICIENT TOOL FOR DISSOLUTIONENHANCEMENT OF DIENOGEST via openalex
- doi:10.1358/mf.1998.20.3.485666 via openalex
- doi:10.1016/j.jconrel.2005.11.013 via openalex
- doi:10.1211/0022357044751 via openalex
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- openalex
- last seen: 2026-05-10T11:33:28.306286+00:00
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