HPLC method development for fampridine using Analytical Quality by Design approach.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Quality by Design (QbD) is crucial for developing robust analytical methods.
• High-performance liquid chromatography (HPLC) is a standard technique in pharmaceutical analysis.

Purpose of the Study:

• To develop and validate a novel HPLC method for fampridine using an experimental design approach.
• To ensure the method meets international guidelines for linearity, accuracy, robustness, and precision.

Main Methods:

• Development of an HPLC method aided by experimental design.
• Preliminary validation according to international guidelines.
• Analysis of fampridine at 262 nm with a 2.9-minute elution time.

Main Results:

• The method demonstrated excellent linearity (R²=0.9996) between 1-15 µg mL⁻¹.
• High mean recovery (98.7 ± 1.9 %) and low relative standard deviation (< 1 %) for precision.
• Achieved limits of detection (0.24 µg mL⁻¹) and quantification (0.78 µg mL⁻¹).

Conclusions:

• The developed HPLC method is rapid, robust, and suitable for fampridine assay in pharmaceutical formulations.
• The QbD approach ensures a reliable and efficient analytical procedure.
• This method supports high-throughput sample analysis in quality control settings.