摘要
目的:建立一种高效液相色谱法测定注射用硫酸头孢匹罗的含量及其有关物质。方法:采用 Mlltima C_(18)柱,以乙腈-0.03 mol·L^(-1)磷酸二氢铵(磷酸调 pH 3.3)(1:7)为流动相,检测波长为270 nm,流速1.0 mL·min^(-1),柱温为室温。结果:主成分与其余杂质峰完全分离,硫酸头孢匹罗在60.1～140.1μg·mL^(-1)浓度范围内呈良好的线性关系,高、中、低3种浓度下的平均回收率在99.1%～99.9%范围内。结论:该方法专属性好,精密度、准确度符合要求,方法可靠,可用于注射用硫酸头孢匹罗的含量及其有关物质的测定。
Objective：To develop HPLC method for the determination of cefpirome sulfate and its related substances in cefpirome sulfate for injection. Methods： The separation was performed on an Alltima C18 column with acetonitrile-0. 03 mol·L^-1 NH4H2PO4（ adjust pH to 3.3 with H3PO4 ）（ 1：7 ）as the mobile phase. The flow rate was 1.0 mL · min^- 1, the detection was set at 270 nm and the column temperature was maintained at room temperature. Results： Cefpirome was completely separated from other impurities. The calibration curve was linear in the range of 60. 1 -140. 1 μg · mL^- ~, the average recovery was within the range of 99. 1% -99.9% for the three con- centration. The method was proved to be specific, accurate and reproducible. Conclusion： The proposed HPLC method could be used for the determination of cefpirome sulfate and its related substances in cefpirome sulfate for injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第12期1487-1489,共3页
Chinese Journal of Pharmaceutical Analysis
