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Polarographic determination of isosorbide dinitrate
Journal of Pharmaceutical Sciences
|January 1, 1976
Summary
A new polarographic method accurately quantifies isosorbide dinitrate in pharmaceuticals. This technique offers a sensitive, precise, and cost-effective alternative for quality control analysis.
Area of Science:
- Analytical Chemistry
- Electrochemistry
- Pharmaceutical Analysis
Background:
- Isosorbide dinitrate is a vasodilator used to treat angina.
- Accurate quantification of organic nitrates is crucial for pharmaceutical quality control.
- Existing analytical methods may have limitations in sensitivity or cost.
Purpose of the Study:
- To develop and validate a polarographic method for the quantitative analysis of isosorbide dinitrate.
- To assess the method's applicability for content uniformity determination in pharmaceutical formulations.
- To compare the polarographic method with existing analytical techniques.
Main Methods:
- Polarographic reduction of isosorbide dinitrate and its mononitrate isomers in aqueous solutions.
- Measurement of current at -1.6 V versus saturated calomel electrode.
- Assay of pharmaceutical formulations using the developed polarographic method.
Main Results:
- The polarographic current was proportional to organic nitrate concentration (10-100 µg/ml).
- The method showed no interference from inorganic nitrate.
- Mononitrate isomers produced an additive response, preventing individual determination.
- Precision and accuracy were comparable to automated colorimetric analysis.
- The method was validated against IR and colorimetric analyses for commercial formulations.
Conclusions:
- Polarography provides a sensitive, specific, and precise method for analyzing isosorbide dinitrate.
- The technique is suitable for single-tablet assay and content uniformity testing.
- This method offers advantages in terms of sample preparation and apparatus cost.