Development of stability-indicating methods for cefquinome sulphate

Area of Science:

• Analytical Chemistry
• Pharmaceutical Chemistry
• Physical Chemistry

Background:

• Cefquinome sulphate is a cephalosporin antibiotic.
• Understanding drug degradation is crucial for pharmaceutical formulation and stability.
• Alkaline hydrolysis is a common degradation pathway for many pharmaceuticals.

Purpose of the Study:

• To investigate the degradation kinetics and mechanism of cefquinome sulphate in alkaline media.
• To determine the influence of pH and temperature on cefquinome sulphate degradation.
• To develop and validate stability-indicating analytical methods for cefquinome sulphate.

Main Methods:

• First derivative spectrophotometry
• High-Performance Liquid Chromatography (HPLC)
• Thin-Layer Chromatography (TLC)
• Kinetic analysis (pH-rate profiles, Arrhenius plots)

Main Results:

• Cefquinome sulphate degradation is dependent on both pH and temperature.
• Hydrolysis exhibits first-order kinetics with respect to hydroxide ion concentration ([OH(-)]) between pH 9 and 11.
• The Arrhenius plot at pH 10 is linear between 65°C and 100°C.
• The activation energy for cefquinome sulphate hydrolysis was determined to be 21.1 kcal mol(-1).
• A stability-indicating TLC method was developed to separate cefquinome sulphate from its alkaline hydrolysis product.

Conclusions:

• Cefquinome sulphate is susceptible to alkaline hydrolysis, with degradation rates influenced by pH and temperature.
• The kinetic data provides valuable insights into the degradation pathway and stability of cefquinome sulphate.
• The developed analytical methods are suitable for monitoring cefquinome sulphate stability in pharmaceutical formulations.