CAJ | 학술논문

目的：建立瑞舒伐他汀钙片有关物质测定方法；方法制备瑞舒伐他汀钙片中8种杂质，以色谱柱：Agilent extend-C18（4.6 mm×250 mm，5μm）；流动相：0.05 M磷酸二氢钠缓冲液（用磷酸调pH至2.0）：乙腈：甲醇=46：20：34；检测波长：242 nm；流速：0.7 mL·min-1为色谱条件，采用对照品对照法计算瑞舒伐他汀钙片中8种杂质的含量；结果瑞舒伐他汀非对映异构体、5-氧化-瑞舒伐他汀、瑞舒伐他汀-5S-内酯在3批瑞舒伐他汀钙片中含量最高；结论规定瑞舒伐他汀钙片中杂质A、B、C的含量不得过0.5%，杂质D、E、F、G、H不得过0.2%，单杂不得过0.2%，总杂质不得过1.5%。
목적：건립서서벌타정개편유관물질측정방법；방법제비서서벌타정개편중8충잡질，이색보주：Agilent extend-C18（4.6 mm×250 mm，5μm）；류동상：0.05 M린산이경납완충액（용린산조pH지2.0）：을정：갑순=46：20：34；검측파장：242 nm；류속：0.7 mL·min-1위색보조건，채용대조품대조법계산서서벌타정개편중8충잡질적함량；결과서서벌타정비대영이구체、5-양화-서서벌타정、서서벌타정-5S-내지재3비서서벌타정개편중함량최고；결론규정서서벌타정개편중잡질A、B、C적함량불득과0.5%，잡질D、E、F、G、H불득과0.2%，단잡불득과0.2%，총잡질불득과1.5%。
Objective To establish the related substance method of rosuvastatin calcium tablets. Methods Prepared eight impurities of rosuvastatin calcium tablets first, Column:Agilent extend-C18 (4.6 mm×250 mm, 5μm) with mobile phase consisted of 0.05 M sodium dihydrogen phosphate buffer (adjusted to pH 2.0 with phosphoric acid):acetonitrile:methanol=46:20:34 at a flow rate of 0.7 mL·min-1 when the detective wavelength was set at 242 nm, used external standard method to calculate the content of impurities. Results The contents of (3S, 5S)-rosuvastatin calcium, 5-oxo-rosuvastatin and rosuvastatin-5S-lactone are more than others in three batches of rosuvastatin calcium tablets. Conclusion The contents of impurity A, B, C should not be more than 0.5% and impurity D, E, F, G, H should not exceed 0.2%, for each unspecified impurities not more than 0.2%and not more than 1.5%for total.