Microanalytical high-performance liquid chromatography assay for cefpirome (HR 810) in serum

Area of Science:

• Analytical Chemistry
• Pharmacokinetics
• Pharmaceutical Analysis

Background:

• Accurate quantification of cefpirome (HR 810) in biological matrices is crucial for pharmacokinetic studies.
• Existing analytical methods may require larger sample volumes or lack the sensitivity needed for pediatric investigations.

Purpose of the Study:

• To develop and validate a microanalytical high-performance liquid chromatography (HPLC) method for determining cefpirome concentrations in human serum.
• To assess the suitability of the developed method for pediatric pharmacokinetic investigations.

Main Methods:

• Serum samples (0.05 ml) were extracted using isopropanol containing beta-hydroxypropyltheophylline as an internal standard.
• Separations were performed on a C18 column with detection at 240 nm using a mobile phase of acetate buffer and methanol.
• Method validation included linearity, sensitivity, analytical recovery, precision, and stability assessments.

Main Results:

• The method demonstrated linearity up to 500 micrograms/ml with a sensitivity of 0.6 micrograms/ml.
• Analytical recovery exceeded 86%, and the between-day coefficient of variation was below 4.2%.
• Cefpirome showed stability in serum for 1 week at 4-8°C and 30 days at -20°C, with no interference from common co-administered drugs.

Conclusions:

• The developed microanalytical HPLC method is sensitive, accurate, and precise for cefpirome quantification in serum.
• The small sample volume and straightforward sample preparation make it highly suitable for pediatric pharmacokinetic studies.