Cefaclor in Biological Fluid: A Stability-Indicating High Performance Liquid Chromatographic (HPLC) Assay

Abstract

Cefaclor may be broken down by oxidation, hydrolysis, and racemization when found in biological fluid. Moreover, a variety of factors, including pH, temperature, carbon dioxide, oxygen, light, humidity, and storage, might speed up this deterioration process. These steps are thus essential for determining the amount of cefaclor in biological fluids and for slowing down or stopping the degradation process when assaying is required. Samples were analyzed using the described technique either without pretreatment or after being treated with perchloric acid and protein precipitation. As an internal standard, sulphamethoxazole was used. Using a lichrospher RP-18 column and a mobile phase 80:20 v/v (potassium dihydrogen phosphate buffer (0.067M): methanol, pH 4.5), chromatographic separation was performed. Hexane-1-sulphonic acid sodium salt (0.002 M) was used as an ion pair, and the flow rate was 1.3 mL/min. A UV detector set at 265 nm was used to monitor cefaclor. It was discovered that pre-sample treatment with plasma protein precipitant and perchloric acid as an acidifying agent improved cefaclor stability. The limit of quantitation was calculated to be 0.25 μg/mL, and the calibration curve was shown to be linear in the 0.25–20 μg/mL range (r2 = 0.999). In conclusion, a reversed phase HPLC method for determining cefaclor in biological fluids was developed that is stability-indicating, accurate, precise, simple, and highly sensitive. It can be effectively utilized in bioequivalence studies and other pharmacokinetic evaluations.