High-performance liquid chromatographic analysis of digoxin formulations

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Digoxin is a critical medication requiring precise quantification.
• Existing analytical methods may lack speed, selectivity, or simplicity.

Purpose of the Study:

• To develop and validate a rapid, selective, and simple high-performance liquid chromatographic (HPLC) assay for digoxin.
• To enable accurate quantitation of digoxin in diverse pharmaceutical formulations.

Main Methods:

• Utilized a conventional octadecyl bonded phase column.
• Employed UV detection at 220 nm.
• Applied the method to tablets, elixir, and injectable formulations.

Main Results:

• Achieved high precision with relative standard deviations of 1.45% (tablets), 1.70% (elixir), and 1.80% (injectables).
• Demonstrated sufficient sensitivity for monitoring tablet content uniformity.
• Successfully resolved potential impurities and degradation products within a 15-minute run time.

Conclusions:

• The developed HPLC assay is a robust and efficient tool for digoxin analysis.
• The method ensures the quality and consistency of digoxin formulations.
• Its speed and sensitivity make it suitable for routine pharmaceutical quality control.