Validated Stability Indicating RP-hplc Method for the Assay of Dienogest in Bulk and Tablet Dosage Form

In: International Journal of Pharmaceutical Quality Assurance · 2013 · vol. 4(02) · doi:10.25258/ijpqa.4.2.2 · W3006606850
article OA: closed CC0 ⤵ 1 in-corpus citation
View on OpenAlex View at publisher
AI-generated summary by gemini-2.5-flash-lite, 2026-07-31

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.

One-sentence paraphrase of the abstract; not a substitute for reading it. No clinical advice. How this works

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

My notes (saved in your browser only)

Condition tags

endometriosis

Citation neighborhood (sparse)

Too few in-corpus citations on either side for a chart; here are the lists.

Cites (2)

Cited by (1)

References (5)

Cited by (1)

Source provenance

openalex
last seen: 2026-05-10T11:33:28.306286+00:00
License: CC0 · commercial use OK