CAJ | 학술논문

目的：建立高效液相色谱法测定消旋卡多曲分散片的有关物质。方法采用C18色谱柱（4.6 mm ×250 mm，5μm），以乙腈-磷酸二氢钾（取磷酸二氢钾1 g与磷酸1 mL，加水溶解并稀释至1000 mL）为流动相，梯度洗脱；检测波长为210 nm。结果各杂质在0.5~16μg·mL-1范围内呈良好的线性关系，平均回收率均在90%~110%之间。结论本方法稳定，操作简单，重现性好，可以有效控制消旋卡多曲分散片中有关物质的量。
목적：건립고효액상색보법측정소선잡다곡분산편적유관물질。방법채용C18색보주（4.6 mm ×250 mm，5μm），이을정-린산이경갑（취린산이경갑1 g여린산1 mL，가수용해병희석지1000 mL）위류동상，제도세탈；검측파장위210 nm。결과각잡질재0.5~16μg·mL-1범위내정량호적선성관계，평균회수솔균재90%~110%지간。결론본방법은정，조작간단，중현성호，가이유효공제소선잡다곡분산편중유관물질적량。
Objective To establish an HPLC method for the determination of related substances in Racecadotril Dis-Persible Tablets. Methods The isolation was executed by a ODS column(4. 6 mm × 250 mm,5 μm)and mobile Phase was acetonitrile-Potassium dihydrogen PhosPhate,gradient elution;The detection wavelength was 210 nm. Results Each imPurity showed a good linear relationshiP within 0. 5~16 μg · mL-1 . The average recovery was between 90% to 110%. Conclusion The method was stable,simPle and rePeatable,and can be used for the quality control of the related sub-stances in Racecadotril DisPersible Tablets.