Stability-indicating assay for mecillinam using high-pressure liquid chromatography.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Mecillinam is an important antibiotic requiring robust quality control measures.
• Stability-indicating assays are crucial for assessing drug degradation and ensuring product efficacy.
• Existing analytical methods may not adequately separate mecillinam from its degradation products.

Purpose of the Study:

• To develop and validate a stability-indicating high-pressure liquid chromatographic (HPLC) method for mecillinam.
• To ensure the method can accurately quantify mecillinam in the presence of related substances and degradation products.

Main Methods:

• Development of a high-pressure liquid chromatographic (HPLC) method.
• Validation of the HPLC method for accuracy and precision.
• Separation and determination of mecillinam, related compounds, and degradation products.

Main Results:

• The developed HPLC method effectively separated mecillinam from seven related compounds and at least one unknown degradation product.
• The method demonstrated good accuracy, comparable to existing UV assays.
• High precision was achieved, with a relative standard deviation (R.S.D.) of +/- 1.0% over seven replicate determinations.

Conclusions:

• The developed HPLC method is suitable as a stability-indicating assay for mecillinam.
• This validated method provides a reliable tool for pharmaceutical quality control and stability testing of mecillinam.