A stability-indicating HPLC method to determine cyproterone acetate in tablet formulations

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Accurate quantification of active pharmaceutical ingredients is crucial for drug safety and efficacy.
• Cyproterone acetate (CA) is a widely used pharmaceutical agent requiring reliable analytical methods.

Purpose of the Study:

• To develop and validate a simple, accurate, and robust liquid chromatographic method for estimating cyproterone acetate in pharmaceutical formulations.
• To establish a method suitable for routine quality control analysis in the pharmaceutical industry.

Main Methods:

• Utilized reversed-phase C18 column chromatography.
• Employed a mobile phase of acetonitrile and water (60:40 ratio) with UV detection at 254 nm.
• Quantified drug concentrations on a weight basis, eliminating the need for an internal standard.

Main Results:

• The developed method demonstrated excellent linearity, accuracy, precision, and selectivity.
• Concentration measurements on a weight basis proved effective in lieu of an internal standard.
• Minimal sample preparation was required, involving only a column guard and prefilter.

Conclusions:

• The developed liquid chromatographic method is simple, accurate, and suitable for routine quality control of cyproterone acetate in pharmaceuticals.
• The method's efficiency and reliability make it a valuable tool for pharmaceutical analysis.
• The straightforward sample preparation further enhances its applicability in quality control settings.