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目的 :建立用高效液相色谱法测定西米替丁注射液含量的方法。方法 :以甲硝唑为内标 ,色谱柱为ODSC18柱 ,甲醇 水 三乙胺 (2 7∶73∶0 1,用磷酸调节PH至 3 5± 0 1)为流动相 ,流速 0 8ml/min ,检测波长 2 2 5nm。结果 :在 5 0～ 30 0 μg·ml-1的浓度范围内具有良好的线性关系 ,r =0 9999,平均回收率为 10 0 3% ,RSD =0 4 %。与美国药典 2 3版方法相比 ,无显著性差异 (P >0 0 5 )。结论 :该方法简便、灵敏、准确可靠 ,适用于西米替丁注射液的含量测定。
Objective: To establish a HPLC method for the determination of cimetidine injection. Methods: Metronidazole was used as the internal standard. The column was ODSC18 column, methanol-water triethylamine (2 7:73:01, adjusted to PH 3 5 ± 0 1 with phosphoric acid) as the mobile phase at a flow rate of 0 8 ml / min , Detection wavelength 225nm. Results: There was a good linear relationship in the range of 50 ~ 30 0 μg · ml-1, r = 0 9999, the average recovery was 103% and RSD was 0.4%. Compared with the United States Pharmacopoeia 23 edition, there was no significant difference (P> 0.05). Conclusion: The method is simple, sensitive, accurate and reliable, suitable for the determination of cimetidine injection.