HPLC法测定西咪替丁注射液中西咪替丁的含量

Determination of Cimetidine in Cimetidine Injection by HPLC

建立HPLC法测定西咪替丁注射液的含量的检测方法。采用高效液相的方法测定西咪替丁中的含量。色谱条件：高效液相仪Agilent 1260；Agilent SB-18色谱柱；流动相：0．05mol／L磷酸二氢钾（pH3．0）：乙腈（90：10）；体积流量1．0mL／min。进样量：10μL，柱温为30℃；检测波长218nm；使用高效液相色谱法可以准确有效地测定西咪替丁注射液的含量。线性范围为2．008—40．16μg／mL，相关系数R2=1．000，线性关系良好；平均回收率为101．7％（RSD1．46％）。本方法专属性好，准确、灵敏，适用于西咪替丁注射液的含量测定及鉴别，结果可靠。

To establish HPLC method for determining the content of cimetidine injection, HPLC was selected to determinate the content of cimetidine. Chromatographic condition：High performance liquid chromatograph Agilent 1260, the separation was performed on Aiglent SB-C18 column. Mobile phase ：0.05 mol/L of potassium dihydrogen phosphate （ pH3.0 ） ： aeetonitrile （ 90：10 ） at flow rate of 1.0 mL/min;the injection volume was 10 μL and the column temperature was 30 ℃. The detection wavelength was set at 218 nm. The results showed that the content of cimetidine injection could be accurately determined by using HPLC method. The linear range of cimetidine was from 2. 008 to 40. 16 μg/mL and correlation coefficient R2 = 1. 000. Linear relationship was good. The average recovery was 101.7% （ RSD 1.46% ）. This method is specific, accurate, sensitive and suitable for determining the content of eimetidine injection and for its identification. The result is reliable.