HPLC法测定注射用亚锡喷替酸中喷替酸的含量

目的：以四丁基硫酸氢铵为离子对试剂，采用离子对反相高效液相色谱法测定注射用亚锡喷替酸中喷替酸的含量。方法：采用SunFireTM C18色谱柱（4.6 mm ×150 mm，5μm），流动相为0.05 mol· L-1醋酸钠缓冲液（pH4.5）-甲醇（95∶5），内含5 mmol· L-1四丁基硫酸氢铵，流量1.0 mL· min-1，检测波长360 nm。结果：喷替酸在1.6～8μg范围内线性良好（ r＝0.9998）；平均加样回收率为99.1％， RSD为1.1％（ n＝9）；不同批号的注射用亚锡喷替酸中喷替酸的含量为100.1％～102.9％。结论：本方法简便、准确，重复性好，适用于注射用亚锡喷替酸的质量控制。

HPLC Determination of Pentetate Acid in Pentetate Acid and Stannous Chloride for Injection

Objective：To establish a reversed-phase HPLC method for determination of pentetate acid in pentetate acid and stan-nous chloride for injection, tetrabutylammonium hydrogen sulfate was used as ion pair reagent.Methods： A SunFireTM C18 ODS column （4.6 mm ×150 mm,5 μm） was adopted with 0.05 mol· L-1 sodium acetate buffer solution-methanol （95∶5） as the mobile phase at a flow rate of 1.0 mL· min-1 ,and detected at 360 nm.Results： The curve was linear in the range of 1.6 -8μg（r=0.9998）,the average recovery was 99.1% and RSD was 1.1%.Contents of pentetate acid in different batches of sample were 100.1%-102.9%.Conclusion： This method is simple, accurate and reproducible for the quantitative analysis of pen-tetate acid in pentetate acid and stannous chloride for injection and can be used for the quality control of the active pharmaceutical ingredient.