CAJ | 학술논문

目的：建立高效液相色谱法测定奥美拉唑镁原料药中有机溶剂醋酸含量。方法以色谱柱：以 X -Bridge TM C18（4.6 mm ×250 mm，5μm）为分离柱，采用等度洗脱，检测波长：210 nm。结果线性关系良好，方法精密度，重复性均符合要求。冰醋酸检测浓度线性范围为0.01～0.06 mg·mL -1（r =0.999994），低、中、高浓度平均回收率（n =9）分别为100.60％、100.38％、100.23％，RSD 分别为2.20％、2.21％、1.60％，最低检测限为0.0050 mg·mL -1。结论该方法可用于奥美拉唑镁原料药中残留溶剂醋酸含量的测定，限度为不得过0.05％（500 ppm）。
목적：건립고효액상색보법측정오미랍서미원료약중유궤용제작산함량。방법이색보주：이 X -Bridge TM C18（4.6 mm ×250 mm，5μm）위분리주，채용등도세탈，검측파장：210 nm。결과선성관계량호，방법정밀도，중복성균부합요구。빙작산검측농도선성범위위0.01～0.06 mg·mL -1（r =0.999994），저、중、고농도평균회수솔（n =9）분별위100.60％、100.38％、100.23％，RSD 분별위2.20％、2.21％、1.60％，최저검측한위0.0050 mg·mL -1。결론해방법가용우오미랍서미원료약중잔류용제작산함량적측정，한도위불득과0.05％（500 ppm）。
Objective To establish a method for the determination of residual acetic acid in Omeprazole Magnesium by HPLC Methods The X - Bridge TM C18(4. 6 mm × 250 mm,5 μm)column was adopted,temperature programming and FID detector was used. Results The solvent had good linear relationship and the precision and reproducibility of the meth-od were in accord with the requests. The linear range of acetic acid was 0. 01 ~ 0. 06 mg·mL - 1(r = 0. 999 994);The aver-age recovery rates of low,middle,high concentration(n = 9)were 100. 60% ,100. 38% ,100. 23% ,respectively and the RSDs were 2. 20% ,2. 21% ,1. 60% ,respectively;LOD was 0. 005 0 mg·mL - 1 . Conclusion This method could be used to determine residual acetic acid in Omeprazole Magnesium. The limit was not more than 0. 05%(500 ppm).