摘要

While determining cefaclor in biological fluid, it could be degraded due to oxidation hydrolysis and racemisation. Furthermore, such degradation process can be accelerated depending on pH, temperature, carbon dioxide, oxygen, light, humidity and storage. Thus such measures are crucial in cefaclor determination in biological fluids and reducing or inhibiting the degradation process while assaying is mandatory. In the developed method, samples were assayed without pretreatment or with perchloric acid and protein precipitation treatment. Sulphamethoxazole as an internal standard was used. Chromatographic separation was carried out on with lichrospher RP-18 column using mobile phase 80:20 v/v (potassium dihydrogen phosphate buffer (0.067M): methanol, pH 4.5), hexane-1-sulphonic acid sodium salt (0.002 M) was used as an ion pair and the flow rate was 13 mL/min. Cefaclor was monitored using UV detector at lambda 265 urn. Pre-sample treatment with perchloric acid as acidifying agent and plasma protein precipitant was found to enhance stability of cefaclor. The calibration curve was demonstrated to be linear in the range of 0.25-20 mu g/mL (r(2) = 0.999) and the limit of quantitation was estimated at 0.25 mu g/mL In conclusion, a stability-indicating, accurate, precise, simple, and highly sensitive reversed phase HPLC method for the determination of cefaclor in biological fluids was developed and can be successfully used in bioequivalence study and other pharmacokinetic evaluation.

  • 出版日期2013