HPLC法测定注射用头孢拉定中L-精氨酸的含量

目的:建立以高效液相色谱法测定注射用头孢拉定中L-精氨酸含量的方法。方法:色谱柱为LiChrospher Diol,流动相为0.01mol.L-1磷酸二氢铵溶液(以磷酸调节pH值至2.0±0.1)-乙腈(25∶75),流速为1.0mL.min-1,柱温为30℃,检测波长为206nm,进样量为20μL。结果:L-精氨酸检测浓度的线性范围为51.2～307.2μg.mL-1(r=0.9999);平均回收率为100.7%,RSD=0.6%。结论:本方法快速、准确、简便,可用于该制剂中L-精氨酸的含量测定。

Determination of L-Arginine Content in Cefradine for Injection by HPLC

OBJECTIVE ： To establish an HPLC method for the determination of the content of L - arginine in cefradine for injection. METHODS： The chromatographic analysis was carried on LiChrospher Diol column, and the mobile phase was composed of 0.01 mol · L^-1 ammonium dihydrogen phosphate buffer solution （adjusted pH to 2.0 ± 0.1 with phosphoric acid） - acetonitrile （25 ： 75） at a flow rate of 1.0 mL · min^ -1; the column temperature was 30 ℃ ; the detection wavelength was 206 nm, and the sample size was 20μL. RESULTS： The linear range of L- arginine was 51.2-307.2μg · mL^-1（ r = 0.999 9） . The average recovery was 100.7% （RSD = 0.6% ） . CONCLUSION： The method is rapid, accurate and simple, and suitable for the determination of L - arzinine in cefradine for iniection.