丁溴东莨菪碱注射液有关物质的研究

Study on the related substances in Scopolamine Butylbromide Injection

目的建立高效液相色谱法测定丁溴东莨菪碱注射液的特定杂质托品酸.方法采用高效液相色谱法,色谱柱为KromasilC18柱（4.6mm×250mm,5μm）,以0.004%磷酸溶液-乙腈（50∶50）配制的0.008mol·L^-1十二烷基硫酸钠溶液为流动相,柱温为40℃,流速为1.2mL·min^-1,检测波长为210nm.结果高效液相色谱各杂质峰与主峰均分离良好;方法的精密度良好;杂质托品酸在2.38～14.31μg·mL^-1（r=0.9999）内线性关系良好;杂质托品酸的检出限为0.48ng.结论该方法简便,专属性强,适用于有关物质的测定.

Objective To establish an HPLC method for the determination of specified impurity in Scopolamine Butylbromide Injection. Methods The separation was carried out on a Kromasil C18column( 4. 6 mm × 250 mm,5 μm),the mobile phase was 0. 004% phosphoric acid solution- acetonitrile( 50∶50),including 0. 008 mol·L- 1sodium lauryl sulfate,the flow rate was 1. 2 m L·min- 1,the column temperature was 40 ℃ and the detection wavelength was 210 nm. Results Any impurity peak in the HPLC chromatogram was separated well from the main peak,the reproducibility and precision of the method were good,the linear range of tropic acid was 2. 38 ~ 14. 31 μg·m L- 1( r = 0. 999 9),detection limit of tropic acid was 0. 48 ng. Conclusion The method was accurate,convenient and suitable for the quality control of related substance in Scopolamine Butylbromine Injection.