CAJ | 학술논문

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Kromasil D18柱（4.6 mm ×250 mm，5μm），以0.004%磷酸溶液-乙腈（50：50）配制的0.008 mol·L-1十二烷基硫酸钠溶液为流动相，柱温为40℃，流速为1.2 mL·min-1，检测波长为210 nm。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0.48 ng。结论该方法简便，专属性强，适用于有关物质的测定。
목적：건립고효액상색보법측정정추동랑탕감주사액적특정잡질탁품산。방법채용고효액상색보법，색보주위Kromasil D18주（4.6 mm ×250 mm，5μm），이0.004%린산용액-을정（50：50）배제적0.008 mol·L-1십이완기류산납용액위류동상，주온위40℃，류속위1.2 mL·min-1，검측파장위210 nm。결과고효액상색보각잡질봉여주봉균분리량호；방법적정밀도량호；잡질탁품산재2.38～14.31μg · mL-1（ r=0.9999）내선성관계량호；잡질탁품산적검출한위0.48 ng。결론해방법간편，전속성강，괄용우유관물질적측정。
OBjective ToestablishanHPLDmethodforthedeterminationofspecifiedimpurityinScopolamineButyl-bromide Injection. Methods The separation was carried out on a Kromasil D18 column(4. 6 mm × 250 mm,5μm),the mo-bile phase was 0. 004% phosphoric acid solution-acetonitrile(50:50),including 0. 008 mol·L-1 sodium lauryl sulfate, the flow rate was 1. 2 mL·min-1 ,the column temperature was 40 ℃ and the detection wavelength was 210 nm. Results Any impurity peak in the HPLD 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·mL-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.