注射用比阿培南的含量测定方法研究

Study on Content Determination of Biapenpem for Injection

目的探讨注射用比阿培南含量测定的最佳方法。方法以紫外分光光度法(UV法)与高效液相色谱法(HPLC法)对样品及对照品进行测定。结果比阿培南浓度与吸收度值或高效液相色谱峰面积均呈良好的线性关系,回归方程分别为A=0.05638C-0.006233(r=0.9998),Y=563807.6+11924676.4C(r=0.9999),两方法回收率、稳定性良好,含量测定差值为±1%。结论用HPLC法测定含量能同时准确监控产品中的有关物质,可更好地控制产品质量。

Objective To establish the suitable method for determination of biapenpem in biapenpem for injection. Methods The content of biapenpem for injection was determined by HPLC and UV. Results The relationship between the biapenpem and the peak area or absorb was linear. The linear regression equations are A = 0. 056 38 C - 0. 006 233, r = 0. 999 8 ; Y = 563 807.6 ＋ 11 924 676.4 C, r = 0. 999 9. The two methods had good average recovery and stability,the different value was ± 1%. Condusion HPLC can determine the content and concurrently control the related substances. HPLC can be used to control the production quality.