HPLC法测定烟酸注射液中烟酸的含量及有关物质

目的 建立高效液相色谱法用于烟酸注射液中烟酸的含量测定及有关物质检查.方法 用碳十八烷基硅烷键合硅胶为填充剂;以乙腈-0.05 mol/L磷酸二氢钠溶液(用磷酸调节pH值至2.5)(1∶99)为流动相;检测波长为262nm.结果 重复性及回收率结果良好,重复性的RSD为0.07％(n=6),烟酸与相关杂质分离度好,烟酸的最低检出限为0.04μg/ml,线性范围为0.004983～ 0.19932 mg/ml(R=0.9999),平均回收率为100.2％(RSD=0.40％).结论 高效液相色谱法准确可靠,可用于烟酸注射液中烟酸的含量测定及烟酸注射液有关物质的检查,操作简便、准确度高.

Concentration and related substances of niacin injection determined by high performance liquid chromatography

Objective To establish a high performance liquid chromatography （HPLC） method for determination of the concentration and related substances in niacin injection. Methods niacin can be separated on Waters symmetry C18 column （5 urn; 4.6 × 150 mm） with a mixture of 0.05 mol/L sodium phosphate （adjust pH value to 2.5 with phosphoric acid）： acetonitrile （99：1） as mobile phase and detected at 262 nm. Results The result of reproducibility was 0.07% （n=6）. Niacin was well separated from other impurity with this method. The lowest detection limit was 0.04 μ g/ml, the standard curve was linear in the concentration range of 0.004 983N0.199 32 mg/ml and the correlation coefficient was 0. 999 9. The average recovery rate was 100.2% （RSD=0.40%）.Conelusion The method is simple and accurate. It is adopted to determine the concentration and related substances of niacin injection.