HPLC method for the analysis of cyproterone acetate in tablets

Area of Science:

• Pharmaceutical Analysis
• Analytical Chemistry
• Chromatography

Background:

• Cyproterone acetate is a steroid used in various pharmaceutical preparations.
• Accurate quantification of active pharmaceutical ingredients is crucial for drug quality and efficacy.
• Existing analytical methods may require optimization for specific applications like dissolution testing.

Purpose of the Study:

• To develop and validate a reversed-phase high-performance liquid chromatography (HPLC) method for cyproterone acetate analysis.
• To assess the method's suitability for quantifying the steroid in tablet formulations.
• To demonstrate the application of the developed HPLC method in dissolution testing.

Main Methods:

• Extraction of cyproterone acetate from tablet matrices.
• Quantification using a C18 reversed-phase column.
• Validation of the method for recovery, linearity, and precision.

Main Results:

• The developed HPLC method provides accurate and precise quantification of cyproterone acetate.
• The procedure is rapid and simple to perform.
• The method demonstrated good recovery and linearity over the tested range.
• Successful application to analyze dilute samples from dissolution studies was achieved.

Conclusions:

• The described reversed-phase HPLC method is a reliable and efficient tool for cyproterone acetate analysis in tablets.
• The method's validity and applicability make it suitable for routine quality control and pharmaceutical research.
• This analytical approach supports the assessment of drug release profiles through dissolution testing.