A stability indicating LC method for felodipine

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Felodipine is a widely used calcium channel blocker.
• Accurate quantification and stability assessment are crucial for pharmaceutical quality control.

Purpose of the Study:

• To develop and validate a stability-indicating reversed-phase liquid chromatographic (RP-LC) method for felodipine assay.
• To ensure the method's suitability for analyzing felodipine in bulk drug and pharmaceutical formulations.

Main Methods:

• Reversed-phase liquid chromatography (RP-LC) using a C18 column.
• UV detection at 238 nm with a mobile phase of methanol-potassium dihydrogen orthophosphate (pH 3.5).
• Statistical validation including linearity, accuracy, precision, and specificity.

Main Results:

• The method demonstrated excellent linearity within the 1-7 microg/ml range.
• Achieved limits of detection (150 ng/ml) and quantitation (500 ng/ml).
• Showed high precision, accuracy, and specificity, with no interference from excipients or degradation products.

Conclusions:

• The developed RP-LC method is suitable for the stability assay of felodipine.
• This validated method provides reliable analysis for both bulk drug and pharmaceutical products.
• The method effectively separates felodipine from its degradation products, ensuring analytical integrity.