HPLC method development for testosterone propionate and cipionate in oil-based injectables

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Accurate quantification of anabolic steroids in pharmaceutical formulations is crucial for quality control.
• Oil-based injectable formulations present unique challenges for analytical method development due to matrix effects.

Purpose of the Study:

• To develop and validate two isocratic liquid chromatographic methods for determining testosterone propionate (TP) and testosterone cypionate (TC) in oil-based injectables.
• To establish reliable analytical procedures for quality control of these pharmaceutical products.

Main Methods:

• Development and validation of two isocratic High-Performance Liquid Chromatography (HPLC) methods.
• Utilized specific mobile phase compositions (57% water:acetonitrile 43% for TP, 54% water:acetonitrile 46% for TC).
• Employed a Luna CN column (250 mm x 4.6 mm i.d., 5 µm) at 25°C, a flow rate of 1 mL/min, and UV detection at 245 nm.
• Sample preparation involved extraction using the surfactant sodium dodecyl sulfate prior to HPLC analysis.

Main Results:

• Achieved baseline separation for both testosterone propionate and testosterone cypionate.
• Methods were validated, indicating suitability for routine analysis.
• Successful quantification of analytes in oil-based injectable matrices.

Conclusions:

• The developed isocratic HPLC methods are effective and validated for the determination of testosterone propionate and testosterone cypionate in oil-based injectables.
• These methods provide a reliable approach for pharmaceutical quality control and analysis of these steroid esters.