摘要
目的建立高效液相色谱法测定氨甲苯酸注射液中氨甲苯酸含量及有关物质的方法。方法采用Agela C18(4.6 mm×200 mm)色谱柱,含0.003 mol.L-1庚烷磺酸钠的0.05 mol.L-1的醋酸钠溶液(用冰醋酸调节pH值至3.0)-甲醇(95∶5)为流动相,240 nm为检测波长。结果氨甲苯酸在0.025～0.40 g.L-1的浓度范围内线性关系良好(r=0.999 8);平均回收率为100.3%,RSD为0.6%(n=9)。结论该方法简便、准确、可靠,专属性强,可以用于氨甲苯酸注射液的质量控制。
Objective To establish an HPLC method for determining the content and its related substances of aminomethylbenzoic acid injection.Methods Agela C18 column was used,0.05 mol·L-1sodium acetate solution containing 0.003 mol·L-1 sodium heptane sulfonic acid（pH adjusted to 3.0 by glacial acetic acid）-methanol（95∶ 5） as mobile phase with UV detection at 240 nm.Results The calibration curve was in good linearity over the range between 0.025 and 0.4 g·L-1（r=0.999 8）.The average recovery was 100.3% and RSD was 0.6%（n=9）.Conclusion The method is simple,accurate,reliable,specific and can be used for the quality control of aminomethylbenzoic acid injection.
出处
《安徽医药》
CAS
2012年第8期1084-1086,共3页
Anhui Medical and Pharmaceutical Journal
