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Stability-indicating methods for the determination of sumatriptan succinate
L I Bebawy1, A A Moustafa, N F Abo-Talib
1National Organization for Drug Control and Research (NODCAR), 6 Hussen Kamal el Deen, Ben-el-sariat, Dokki, 12311, Giza, Egyp. gamella@is-egypt.com
Journal of Pharmaceutical and Biomedical Analysis
|August 9, 2003
Summary
This study presents four stability-indicating methods for analyzing sumatriptan succinate, even with degradation products present. These analytical techniques ensure accurate quantification in various forms, including pharmaceutical tablets.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Sumatriptan succinate is a crucial medication requiring reliable analytical methods for quality control.
- Ensuring the stability and accurate quantification of sumatriptan succinate in pharmaceutical formulations is vital.
Purpose of the Study:
- To develop and validate four stability-indicating analytical methods for sumatriptan succinate.
- To assess the accuracy and precision of these methods in the presence of degradation products.
Main Methods:
- Quantitative densitometric evaluation of thin-layer chromatography (TLC).
- First-derivative (D1) and second-derivative (D2) spectrophotometry.
- Ratio derivative spectrophotometric technique.
Main Results:
- TLC method showed high recovery (100.52%) for sumatriptan succinate.
- Spectrophotometric methods (D1, D2, and ratio derivative) demonstrated excellent recovery (around 99.9-100.2%) within specified concentration ranges.
- All methods proved effective for analyzing sumatriptan succinate in bulk powder, mixtures, and Imigran tablets.
Conclusions:
- The developed methods are robust, accurate, and precise for sumatriptan succinate determination.
- These stability-indicating methods offer reliable options for pharmaceutical quality control and analysis.
- The study successfully validated analytical techniques for sumatriptan succinate in complex matrices.