Separation and quantification of ropinirole and some impurities using capillary liquid chromatography

Area of Science:

• Analytical Chemistry
• Pharmaceutical Science

Background:

• Ropinirole is a key medication for Parkinson's disease.
• Ensuring the purity of pharmaceutical compounds is critical for patient safety and drug efficacy.
• Identifying and quantifying synthesis-related impurities is essential for drug development and manufacturing.

Purpose of the Study:

• To develop and optimize a capillary liquid chromatography (CLC) method for the separation and quantification of ropinirole and its related impurities.
• To establish a sensitive and efficient analytical technique for quality control of ropinirole.

Main Methods:

• Capillary liquid chromatography (CLC) with a C18 reversed stationary phase was employed.
• A simultaneous optimization of mobile phase parameters (pH, buffer concentration, acetonitrile content) was conducted using an experimental design approach.
• Isocratic elution mode was used with a mobile phase flow rate of 4 µL/min.

Main Results:

• Baseline resolution of ropinirole and five related impurities was achieved.
• An optimized mobile phase composition [acetonitrile-8.7 mM 2-(N-morpholino)ethanesulfonic acid adjusted to pH 6.0 (55:45, v/v)] was determined.
• The CLC method demonstrated the ability to quantify impurities down to 0.06% of the main component within 25 minutes.

Conclusions:

• Capillary liquid chromatography is a powerful and efficient tool for the analysis of ropinirole and its impurities.
• The developed method provides a reliable approach for pharmaceutical quality control, ensuring the purity of ropinirole.
• This analytical method contributes to the safety and quality assurance of anti-Parkinson's disease medication.