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Simultaneous quantification of released succinic acid and a weakly basic drug compound in dissolution media
1Institute for Pharmacy and Food Chemistry, Munich, Germany. prof.thoma@Irz.uni-muenchen.de
Summary
A new HPLC method accurately quantifies fenoldopam and succinic acid in dissolution media. This stability-indicating assay ensures reliable drug analysis and peak purity for fenoldopam formulations.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Succinic acid, a pH adjuster for fenoldopam, has low UV absorption, complicating its analysis.
- Traditional assays for succinic acid are unsuitable in dissolution media due to low pH, buffer salts, and the presence of fenoldopam.
Purpose of the Study:
- To develop a simple, accurate, and reproducible HPLC method for simultaneous quantification of fenoldopam and succinic acid.
- To establish a stability-indicating assay for fenoldopam dissolution testing.
Main Methods:
- A non-ion-pair reversed-phase HPLC method utilizing a fast-scanning UV detector and PC software.
- Detection of succinic acid at 205 nm and fenoldopam at 225 nm.
- UV spectrum analysis for peak purity determination and peak identification (99.9% match).
Main Results:
- Simultaneous quantification of fenoldopam and succinic acid was achieved with accuracy, precision, and specificity.
- The method demonstrated a linear range suitable for dissolution testing concentrations.
- Peak purity analysis confirmed accurate quantification, preventing interference from unknown peaks.
Conclusions:
- The developed HPLC method is suitable for simultaneous fenoldopam and succinic acid determination in dissolution testing.
- The method is stability-indicating and can also quantify fumaric acid, another pH adjuster.
- This assay provides reliable and reproducible results for pharmaceutical quality control.