Determination of Dienogest in Pure Form and Pharmaceutical Preparation by Stability-indicating Spectrophotometric Method | Chapter 4 | Challenges and Advances in Chemical Science Vol. 9

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.

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Method Development and Validation for the Estimation of Adefovir Dipivoxil in Bulk and Pharmaceutical Dosage Forms and Its Stress Degradation Studies Using UV-Vis Spectrophotometric Method: Experimental Investigation| Chapter 10 | Current Aspects in Pharmaceutical Research and Development Vol.9

 Objective: To create a UV-VIS Spectrophotometric method for measuring adefovir, an anti-HIV medication, in bulk and pharmaceutical dose form that is simple, accurate, precise, and cost-effective.

The solvent employed was methanol, and the drug's maximum absorption peak was found to be 260 nm. Under ICH-recommended circumstances, defovir dipivoxil was subjected to stress degradation. The samples obtained this way were used in deterioration tests using the described approach.

With a regression coefficient of 0.999, a linear response was seen in the range of 5- 40g/ml. The approach was then tested for a number of parameters using ICH (International Conference on Harmonization) guidelines. Adefovir dissolves in acidic and alkaline environments, but stays relatively stable when subjected to dry heat, oxidation, and photolysis, according to stress degradation tests.

Conclusion: Without the use of excipients, this method can be used to determine adefovir in formulation quality control.

Author(s) Details:

Charushila H. Bhirud,
Pravara Institute of Medical Sciences Deemed University (PIMS), Loni, Maharashtra, India.

Shivanand N. Hiremath,
Department of Pharmaceutical Sciences, Pravara Rural College of Pharmacy for Women, Chincholi, Nasik, Pin-422102, Maharashtra, India.

Please see the link here: https://stm.bookpi.org/CAPRD-V9/article/view/5970