HPLC法测定注射用头孢匹胺钠中苯甲酸钠含量方法研究

目的建立HPLC法测定注射用头孢匹胺钠中苯甲酸钠含量的方法。方法 HPLC法,采用资生堂MGII C18柱(250mm×4.6mm,5μm),以0.03mol/L的乙酸铵(用氨水调节pH至7.5)-甲醇(75:25)为流动相,流速为1m L/min,柱温为35℃,检测波长为254nm,进样量为20μL。结果苯甲酸钠在浓度5.963~149.080μg/m L范围内,呈良好的线性关系,回归方程y=6034.2x+1581.9,相关系数r=1.0000;定量限为0.15μg/m L,平均回收率(n=9)为101.5%。结论该方法专属性良好、准确、快捷,精密度及耐用性好;可用于注射用头孢匹胺钠中苯甲酸钠含量测定,并对其药品质量控制提供了参考依据。

Research of process rationality of cefpiramide for injection

bjective Establishment of an HPLC method for the determination of sodium benzoate in cefpiramide sodium for injection. Methods The analysis was performed on a SHISEIDO C18 MGⅡcolumn (250mm×4.6mm, 5μm) with a mobile phase of 0.03mol/L ammonium acetate (with ammonia pH adjusted to 7.5)-methanol (75:25). The flow rate was 1.0mL/min. The detection wavelength was 254nm and the column temperature was 35℃. The injection volume was 20μL. Results This method had good specificity. The calibration curve was linear within the range of 5.963~149.080μg/mL for sodium benzoate. The regression equation was y=6034.2x+1581.9 (r=1.0000). The limit of quantitation was 0.15μg/mL. The recoveries (n=9) were 101.5%. Conclusion The method was specific, accurate, fast and durable. It can be used to determine the content of sodium benzoate in cefpiramide sodium for injection, which can used in the quality control of cefpiramide sodium for