HPLC method development and validation for the determination of Cefaclor in human plasma

Area of Science:

• Analytical Chemistry
• Pharmacokinetics

Background:

• Accurate quantification of Cefaclor in human plasma is crucial for pharmacokinetic studies and therapeutic drug monitoring.
• Existing analytical methods may lack the required sensitivity, specificity, or simplicity for routine clinical or research applications.

Purpose of the Study:

• To develop and validate a simple, precise, and accurate assay method for the determination of Cefaclor in human plasma using high-performance liquid chromatography (HPLC).

Main Methods:

• Development of a reversed-phase HPLC method utilizing a C-18 column.
• Optimization of mobile phase composition (sodium 1-pentanesulfonate, water, triethylamine, methanol) and pH (2.5±0.1).
• Detection of Cefaclor at a wavelength of 265 nm with a flow rate of 1.5 ml/min.

Main Results:

• The developed HPLC method demonstrated excellent linearity (R² = 0.999) within the concentration range of 0.39 µg/ml to 50 µg/ml.
• The method was fully validated for selectivity, accuracy, precision, repeatability, reproducibility, recovery, and stability.
• Cefaclor exhibited a retention time of 17 minutes under the optimized chromatographic conditions.

Conclusions:

• The validated HPLC assay method is simple, accurate, precise, and suitable for the reliable determination of Cefaclor in human plasma.
• This method can be effectively employed for pharmacokinetic studies, therapeutic drug monitoring, and quality control of Cefaclor formulations.