The current study describes a UV-spectrometric approach for estimating dienogest in commercial formulations that is very sensitive to stability indicators. For the determination of dienogest and its degradants in bulk powder and pharmaceutical preparations, simple, rapid, sensitive, accurate, and precise stability-indicating spectrophotometric methods were devised. The methods were successfully applied to the determination of dienogest at 297 nm with an average percent recovery of 93.9 – 100.3. They were validated over a linear range of 1 – 5 g/mL and successfully applied to the determination of dienogest at 297 nm with an average percent recovery of 93.9 – 100.3. Dienogest was put through its paces under ICH-recommended stress settings. The samples obtained in this way were used in the developed method's degradation studies. The proposed procedures have been validated and can be used to examine dienogest-containing formulations. In compliance with ICH recommendations, a simple, accurate, precise, robust, and quick UV visible spectrophotometric technique for quantifying dienogest in pharmaceutical dosage form has been developed and validated.
Author (s) Details
Ms. L. Mumtha
Department of Pharmacognosy, JSS College of Pharmacy, Ooty, Tamil Nadu, India.
S. N. Meyyanathan
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Ooty, Tamil Nadu, India.
S. T. Narenderan
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Ooty, Tamil Nadu, India.
View Book :- https://stm.bookpi.org/CACS-V9/article/view/6449
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