Determination of cefotaxime and sulbactam concentrations in human biological sample by RPª²HPLC

    GU Yi, WANG Xiaoª²Juan, WANG Rong, BAI Juanª²Juan, GAO Suª²Li

    Department of Pharmacy, Stomatological Hospital, Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi¬ðan 710033, China

    ¡¾Abstract¡¿ AIM: To establish a determination method of concentrations in human biologic sample following intravenous administration of cefotaxime and sulbactam. METHODS: A RPª²HPLC method was developed and validated to determine cefotaxime and sulbactam in plasma and urine. The mobile phase of cefotaxime and sulbactam consisted of 1 g/L triethylamine (regulated with phosphate acid to pH=6.2) and methanol in a 68¡Ã32 and 84¡Ã16 (v/v) respectively and pumped at a flow rate of 1 mL/min. The plasma samples were deproteinated by addition of methanol, the urine samples were diluted with super pure water, then 20 ¦ÌL of supernatant was injected onto a C18 column and monitored with UV detector at 254 nm and 220 nm respectively. RESULTS: The assay of cefotaxime in human plasma and urine were linear over the range of 5.3-530.0 mg/L and 5.45-545.00 mg/L respectively, with the detection limit of 1 mg/L and 0.25 mg/L respectively. The assay of sulbactam in human plasma and urine were linear over the range of 1.04-208.00 mg/L, with the detection limit of 0.50 mg/L and 0.25 mg/L respectively. The average recovery of the method was (89-110)%, and the RSD within and between days were all less than 5%. The cefotaxime and sulbactam sample of plasma and urine stored in a -20¡æ refrigerator became stable within 3 d. CONCLUSION: The assay method is rapid, accurate and usable for the determination of cefotaxime and sulbactam concentrations in plasma and urine. ......