高效液相色谱法测定尼扎替丁氯化钠注射液的含量和有关物质

Determination of nizatidine and related substances in its nizatidine injection by HPLC

目的:建立RP-HPLC测定尼扎替丁氯化钠注射液含量测定和有关物质检查的方法。方法:采用RP-HPLC,色谱柱:Diamonsil C18 column(250nm×4.6nm,5μm),流动相:乙腈-0.025mol·L-1磷酸二氢钾溶液,流速:1.0mL·min-1,检测波长:242nm。结果:该法的线性范围为0.5mg·mL-1-1.5mg·mL-1,平均回收率100.1%,RSD=0.52%。结论:本法分离效果佳,灵敏度高,重现性好,结果准确可靠。

Objective:To develop a HPLC method for the determination of nizatidine and related substances in its nizatidine injection. Methods:A HPLC method was used with a column of Diamonsil C18 (4.6mm×250 mm,5μm),using acetonitrile-0.025M potassium dihydrogen phosphate as the mobile phase. The flow rate was 1.0 mL·min-1, and the wavelength of determination was 242nm.Results: The linear range was 0.5mg·mL-1～1.5mg·mL-1,The average recovery was 100.1%, RSD= 0.52%.Conclusions: The method is simple and convenient,high sensitivity and good reproduction quality.