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目的建立尼扎替丁注射液中尼扎替丁的含量测定方法。方法采用反相高效液相色谱法(RP-HPLC),Hypersil ODS C18色谱柱;乙腈-0.1mol/L的醋酸铵溶液(15:85,每100ml中加0.6ml的三乙胺,用醋酸调节pH至8.5)为流动相;检测波长为242nm;流速:1.0ml/min。结果尼扎替丁在2.5~20.0μg/ml范围内具有良好的线性关系,平均加样回收率为98.67%,RSD为1.03%。结论本方法准确可靠,重现性好,可用于尼扎替丁注射液中尼扎替丁的含量测定。
Objective To establish a method for the determination of nizatidine in nizatidine injection. Methods RP-HPLC was performed on a Hypersil ODS C18 column. Acetonitrile-0.1mol / L ammonium acetate solution (15:85, 0.6ml triethylamine per 100ml) was adjusted with acetic acid pH to 8.5) as mobile phase; detection wavelength was 242 nm; flow rate: 1.0 ml / min. Results Nizatidine showed a good linearity in the range of 2.5-20.0 μg / ml with an average recovery of 98.67% and a RSD of 1.03%. Conclusion The method is accurate and reproducible, and can be used for the determination of nizatidine in nizatidine injection.