CE-C(4)D method development and validation for the assay of ciprofloxacin

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic crucial for treating various bacterial infections.
• Accurate and reliable quantification methods are essential for pharmaceutical quality control.

Purpose of the Study:

• To develop and validate a capillary electrophoresis method with capacitively coupled contactless conductivity detection (CE-C(4)D) for ciprofloxacin determination.
• To optimize the method using a Quality by Design (QbD) approach for robustness and accuracy.

Main Methods:

• Method development focused on Quality by Design (QbD), exploring various buffers and ionic strengths.
• Optimized conditions involved monosodium citrate buffer, uncoated fused silica capillary, and hydrodynamic injection.
• Separation achieved at 20kV with LiCl as an internal standard.

Main Results:

• The optimized CE-C(4)D method demonstrated high accuracy (recovery >98%) and linearity (R(2)>0.999) over a concentration range of 0.0126-0.8mg/mL.
• Excellent intra-day (<3%) and inter-day (3.1%) repeatability was achieved.
• The method showed no matrix interference and provided accurate ciprofloxacin content (102%), meeting official requirements.

Conclusions:

• A robust, accurate, and precise CE-C(4)D method for ciprofloxacin quantification has been successfully developed and validated.
• The method's simplicity and robustness make it suitable for diverse laboratory settings, including those with less stringent controls.
• This validated method contributes to reliable pharmaceutical analysis and quality assurance of ciprofloxacin.