CAJ | 학술논문

目的：：建立高效分子排阻色谱法( HPSEC)分析拉氧头孢钠中的聚合物等杂质。方法：采用以球状蛋白色谱用亲水硅胶为填料的色谱柱Zenix SEC-150(7.8 mm ×300 mm,3μm)；流动相为磷酸盐缓冲液(pH 7.0)[0.005 mol·L-1磷酸氢二钠溶液-0.005 mol·L-1磷酸二氢钠溶液(61∶39)]-乙腈(95∶5)；流速为0.8 ml·min-1；检测波长为254 nm；柱温为25℃；进样量为10μl。结果：拉氧头孢钠和聚合物等杂质能很好分离,拉氧头孢的线性范围为0.98~97.73μg·ml-1(r=0.9999)；定量限为2.9 ng、检出限为1.0 ng；样品测定的线性范围为0.45~2.80 mg·ml-1(r=0.9995)。结论：该方法简便快速、定量准确、重复性好,可用于拉氧头孢钠中聚合物等杂质的检验。
목적：：건립고효분자배조색보법( HPSEC)분석랍양두포납중적취합물등잡질。방법：채용이구상단백색보용친수규효위전료적색보주Zenix SEC-150(7.8 mm ×300 mm,3μm)；류동상위린산염완충액(pH 7.0)[0.005 mol·L-1린산경이납용액-0.005 mol·L-1린산이경납용액(61∶39)]-을정(95∶5)；류속위0.8 ml·min-1；검측파장위254 nm；주온위25℃；진양량위10μl。결과：랍양두포납화취합물등잡질능흔호분리,랍양두포적선성범위위0.98~97.73μg·ml-1(r=0.9999)；정량한위2.9 ng、검출한위1.0 ng；양품측정적선성범위위0.45~2.80 mg·ml-1(r=0.9995)。결론：해방법간편쾌속、정량준학、중복성호,가용우랍양두포납중취합물등잡질적검험。
Objective:To establish a high performance size-exclusion chromatography ( HPSEC) method for the determination of impurities including polymers in latamoxef sodium. Methods:The analysis was performed on a Zenix SEC-150 column(7. 8 mm × 300 mm, 3 μm)with the mobile phase of 0. 005 mol·L-1 phosphate buffer solution [0. 005 mol·L-1 disodium hydrogen phosphate-0. 005 mol·L-1 sodium dihydrogen phosphate (61∶39), pH 7. 0] at a flow rate of 0. 8 ml·min-1. The detection wavelength was set at 254 nm. The column tempretrue was 25℃ and the injection volume was 10μl. Results:The impurities including polymers in latamoxef so-dium were completely separated from latamoxef. The linear range of latamoxef was 0. 98-97. 73 μg·ml-1(r=0. 999 9). The limit of quantitation of latamoxef was 2. 9 ng, and the detection limit was 1. 0 ng. The linear range of the total impurities was 0. 45-2. 8 mg· ml-1(r=0. 999 5). Conclusion: The established method is accurate, rapid and reproducible, and suitable for the determination of impurities including polymers in latamoxef sodium.