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Stability-indicating colorimetric assay for indicine N-oxide using TLC
Journal of Pharmaceutical Sciences
|April 1, 1980
Summary
A new method quantifies indicine N-oxide degradation products using a colorimetric assay. This technique offers high recovery and reproducibility for accurate chemical analysis.
Area of Science:
- Analytical Chemistry
- Organic Chemistry
Background:
- Indicine N-oxide is a compound prone to degradation.
- Accurate quantification of degradation products is crucial for stability studies.
Purpose of the Study:
- To develop and validate a sensitive colorimetric assay for quantifying indicine N-oxide degradation products.
Main Methods:
- Aqueous solutions containing indicine N-oxide were acidified to pH 2-4.
- Degradation products were isolated using thin-layer chromatography (TLC).
- A modified procedure converted the drug to a pyrrole, coupled with 4-dimethylaminobenzaldehyde, and measured absorbance at 566 nm.
Main Results:
- The assay demonstrated a high apparent molar absorptivity (epsilon) of 6.13 x 10^4.
- Average recovery of indicine N-oxide was approximately 92%.
- The method exhibited excellent reproducibility with a coefficient of variation of 4.4%.
Conclusions:
- The developed colorimetric assay is a reliable and reproducible method for quantifying indicine N-oxide degradation.
- This assay can be valuable for stability testing and quality control of pharmaceutical formulations containing indicine N-oxide.