An RP-HPLC-UV Method with SPE for Cefotaxime in All-in-One Total Parenteral Nutritional Admixtures: Application to Stability Studies

Abstract

Abstract A simple and selective RP-HPLC-UV method with SPE was developed and validated for the quantification of cefotaxime in all-in-one total parenteral nutrition (AIO-TPN) admixtures. Chromatographic separation was achieved on a 5 μm particle size C18 DB column (250 × 4.6 mm id) using the mobile phase ammonium acetate (25 mM, pH 4.0)–50% acetonitrile in methanol (80 + 20, v/v). The flow rate was 0.9 mL/min and the detection wavelength was 254 nm. The analyte was extracted from AIO-TPN admixtures by means of an SPE method. The cefotaxime calibration curve was linear over a concentration range of 100–1400 μg/mL with a correlation coefficient of ≥0.9994. The intraday accuracy and precision for cefotaxime were ≤–3.15 and ≤3.08%, respectively, whereas the interday accuracy and precision were ≤–2.48 and ≤2.25%, respectively. The method was successfully applied to stability studies of cefotaxime in the presence of micronutrients together with low and high concentrations of macronutrients in AIO-TPN admixtures. Cefotaxime was degraded by 13.00 and 26.05% at room temperature (25 ± 2°C) after 72 h in low and high macronutrient concentration formulations of AIO-TPN admixtures, respectively. The values of cefotaxime degradation rates for low and high macronutrient concentration formulations of AIO-TPN admixtures were –0.164 and –0.353, respectively. These results indicated that there was higher rate of degradation in the AIO-TPN admixture formulations containing high concentrations of macronutrients.