HPLC测定注射用头孢曲松钠舒巴坦钠的含量

Determination of Ceftriaxone sodium/Sulbactam sodium for injection by HPLC

目的 建立测定注射用头孢曲松钠舒巴坦钠含量的方法。方法 采用HPLC法，色谱柱为AlltechAlhimaC18（250mill×4．6mm，5μm）；柱温30℃；流动相为5mmol·L^-1四丁基氢氧化铵的磷酸二氢钾溶液（30mmol·L^-1）-乙腈（90：10）（用磷酸调pH3．8）；流速1．0ml·min^-1；检测波长220nm；进样20μl。结果 头孢曲松的线性范围为0．0G～0．50mg·ml^-1（r=0．9999），平均回收率为99．4％；舒巴坦的线性范围为0．05～0．33mg·ml^-1（r=0．9999），平均回收率为99．6％（n=6）。结论 所建方法简便、快速，准确可靠，可作为本制剂质量控制的方法。

OBJECTIVE To establish an HPLC method for determination of the content of Ceftriaxone Sodium/sulbactam Sodium for injection. METHODS The analytical column was Alhech Alhima CIS （250 mm × 4.6 mm,5 μm）. The mobile phase was a mixture of 5 mmol·L^-1 tetrabutylammonium hydroxide in 30 mmol· L^-1 monobasic potassium phosphate- acetonitrile （90 ： 10 ）, adjusted with phosphoric acid to pH 3.8. The flow rate was 1.0 ml· min^-1 , the detection wavelength was 220 nm. RESULTS The calibration curve for Ceflriaxone was linear in the range from 0.08 mg· ml ^- 1 to 0.50 mg· ml^ -1 , with r of 0. 9999, precision of 0.2% , the repeatability of 0.2% - 0.7% and the average recovery of 99.4%. The calibration curve for Sulbactam was linear in the range from 0.05 mg· ml^- 1 to 0.33mg· ml^- 1 , with r of 0.9999, precision of 0.2% , the repeatability was 0, 3% - 1.6% and the average recovery of 99. 6%. CONCLUSION The method is simple, specific, accurate and reproducible for the assay of Ceftriaxone sodium/Sulbactam sodium for injection.