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目的:建立盐酸头孢他美醋片含量测定及其有关物质检查的HPLC方法。方法:色谱柱为Hypersil ODS2 C_(18)(250mm×4.6 mm,5μm),流动相为0.005 mol·L~(-1)四丁基氢氧化铵溶液-乙腈(64:36,用磷酸调节pH至4.5),流速为1.0ml·min~(-1),检测波长为232 nm,柱温为30℃,进样量10μl。结果:头孢他美与其他有关检查物质能完全分离,其线性回归方程为Y=2.29×10~4X-4.30×10~4(r=0.999 9)表明头孢他美在51.01~510.07μg·ml~(-1)的浓度范围内与峰面积线性关系良好。头孢他美平均加样回收率为99.60%,RSD为0.84%(n=9)。结论:该方法简便、准确,专属性强,可用于盐酸头孢他美醋片的含量和有关物质测定。
Objective: To establish an HPLC method for the determination of ceftazidime hydrochloride tablets and its related substances. METHODS: The chromatographic column was Hypersil ODS2 C 18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.005 mol·L -1 tetrabutylammonium hydroxide solution (64:36, adjusted to pH 4.5 with phosphoric acid ), The flow rate was 1.0ml · min ~ (-1), the detection wavelength was 232 nm, the column temperature was 30 ℃ and the injection volume was 10μl. Results: The ceftazidime was completely separated from other relevant test substances. The linear regression equation was Y = 2.29 × 10 ~ 4X-4.30 × 10 ~ 4 (r = 0.999 9), indicating that ceftazidime was between 51.01 ~ 510.07μg · ml ~ (-1) concentration range and the peak area of a good linear relationship. The average recoveries of ceftazidime were 99.60% with RSD of 0.84% (n = 9). Conclusion: The method is simple, accurate and specific. It can be used for the determination of cefmetazole hydrochloride tablets and related substances.