CAJ | 학술논문

目的：：建立谷氨酸诺氟沙星氯化钠注射液中有关物质的检测方法,并与现行方法进行比较。方法：色谱柱：Diamonsil C18(2)(250 mm×4.6 mm,5μm)；流动相：A为0.025 mol·L-1磷酸溶液-乙腈(87∶13),B为乙腈,梯度洗脱,流速：1.0ml· min-1；检测波长：278 nm 、262 nm；进样量：20μl；柱温：25℃。结果：在梯度洗脱的条件下,样品的稳定性及分离度良好。杂质A在0.032~3.179μg·ml-1范围内线性关系良好(r=1.0000),检出限为0.159 ng,平均回收率为98.3%, RSD为0.64%(n=9)。结论：梯度洗脱方法结果准确、灵敏度高、专属性强、重复性好,可用于谷氨酸诺氟沙星氯化钠注射液有关物质的检测。
목적：：건립곡안산낙불사성록화납주사액중유관물질적검측방법,병여현행방법진행비교。방법：색보주：Diamonsil C18(2)(250 mm×4.6 mm,5μm)；류동상：A위0.025 mol·L-1린산용액-을정(87∶13),B위을정,제도세탈,류속：1.0ml· min-1；검측파장：278 nm 、262 nm；진양량：20μl；주온：25℃。결과：재제도세탈적조건하,양품적은정성급분리도량호。잡질A재0.032~3.179μg·ml-1범위내선성관계량호(r=1.0000),검출한위0.159 ng,평균회수솔위98.3%, RSD위0.64%(n=9)。결론：제도세탈방법결과준학、령민도고、전속성강、중복성호,가용우곡안산낙불사성록화납주사액유관물질적검측。
Objective:To detect the related substances in norfloxacin glutamate and sodium chloride injections on the basis of nor-floxacin related substances analysis method described in Chinese Pharmacopoeia 2010 edition to establish a more scientific and feasible method. Methods:HPLC was performed under the following conditions:a Diamonsil C18(2)(250 mm ×4.6 mm,5μm) column, mo-bile phase A of 0. 025 mol·L-1 phosphoric acid-acetonitrile(87∶13), phase B of acetonitrile, with gradient elution at a flow rate of 1. 0 ml·min-1 , the detection wavelength of 278nm and 262nm, the injection volume of 20 μl, and the column temperature of 25℃. Results:Under the HPLC conditions, the samples had good stability and separation. An excellent linear relationship was achieved within the range of 0. 032-3. 179μg·ml-1(r=1. 000 0),the detection limit of impurity A was 0. 159 ng,and the average recovery was 98. 3% with RSD of 0. 64%(n=9). Conclusion:Compared with the existing methods, the gradient elution method is accurate, sen-sitive, specific and reproducible, and can be used in the determination of related substances in norfloxacin glutamate and sodium chlo-ride injections.