An RP-HPLC-UV method with SPE for cefotaxime in all-in-one total parenteral nutritional admixtures: Application to stability studies

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 AIOTPN 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 AIOTPN admixtures were -0.164 and -0.353, respectively. These results indicated that there was a higher rate of degradation in the AIO-TPN admixture formulations containing high concentrations of macronutrients.