A stability-indicating HPLC method for medroxyprogesterone acetate in bulk drug and injection formulation

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Medroxyprogesterone acetate (MPA) is a critical pharmaceutical agent.
• Ensuring the quality and stability of MPA formulations is essential for patient safety and therapeutic efficacy.

Purpose of the Study:

• To develop and validate a stability-indicating High-Performance Liquid Chromatography (HPLC) assay method for MPA.
• To assess the method's suitability for quality control and stability studies of MPA in bulk drug and injectable suspension.

Main Methods:

• Development of an isocratic reversed-phase HPLC method using a C18 column.
• Utilization of a mobile phase comprising methanol and acetate buffer (pH 5).
• Detection of MPA at 245 nm using a photodiode array detector; stress testing under hydrolysis and oxidation conditions.

Main Results:

• The HPLC method achieved excellent resolution (>or=2) between MPA and its degradation products (megestrol acetate) and preservatives (methyl paraben, propyl paraben).
• Validation demonstrated the method's selectivity, linearity, accuracy, precision, and solution stability.
• The assay method proved effective in separating MPA from related substances and impurities.

Conclusions:

• The developed stability-indicating HPLC method is suitable for the quality control of medroxyprogesterone acetate.
• The method is reliable for assessing the stability of MPA in both bulk drug and injectable suspension forms.