微生物法和高效液相色谱法测定头孢他啶浓度方法学比较

Comparison between microbiological assay and high liquid chromatography for ceftazidime

目的比较高效液相色谱法（HPLC）和微生物法测定头孢他啶浓度的准确性，敏感性和线性范围，探讨两种方法的临床应用。方法建立HPLC和微生物学测定头孢他啶浓度的方法；并分别使用两种方法测定同时测定同种标本中药物浓度。结果HPLC法线性范围为0．25—128mg·L^-1，回收率为（94．34—100．06）％，日内、日间RSD分别为（3．7～6．35）％和（8．12-9．53）％；微生物法线性范围为0．5～128mg·L^-1，回收率为（97．40～101．8）％，日内、日间RSD分别为（4．95-6．29）％和（6．53～7．98）％。结论两种方法回收率和精密度差异无显著性，但微生物学方法更加简单、便捷，成本低廉，适合临床实验室使用。

Aim To compare accuracy, sensitivity and linearity range of high- performance liquid chromatography （HPLC） and microbiological assay for termination of ceftazidime,study clinical application of the two methods. Methods An HPLC method and microbiological assay were established for the determination of concentration of ceftazidime, and the same sample concentrations were determined by the two methods at same time respectively. Results The calibration curve of HPLC method was linear in the range of 0.25 - 128 mg · L^-1 The recovery of HPLC method was within 94.34% and 100.06%. Within-day and day-to-day RSD were 3.7% - 6.35% and 8.12% -9.53% ,respectively. The calibration curve of microbiological assay was in the range of 0.5 - 128 mg · L^-1. The recovery of microbiological assay was within 97.40% and 101.8%, and within-day and day-to-day RSD were 4.95% - 6.29% and 6.53% - 7.98% , respectively. Conclusion There is no significant difference in recovery and precision of two methods, but the microbiological assay is simpler, more convenient, lower-cost, and suitable for clinical laboratory.