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目的:建立离子色谱法测定头孢噻吩钠中的钠离子含量,并考察其成盐状态。方法:分析柱为TSKgel Super IC-CR阳离子柱(150 mm×4.6 mm,3.0μm),流动相为2.2 mmol·L-1甲烷磺酸与1 mmol·L-118-冠-6-醚的混合溶液,流速为0.8 ml·min-1,柱温为40℃,进样量为20μl。检测器为电导检测器。结果:钠离子在3.0~60.0μg·ml-1范围内线性关系良好(r=0.999 9),平均回收率为99.8%(RSD=0.8%,n=9)。样品中钠离子与头孢噻吩酸的摩尔数比在0.97~1.03之间。结论:所建立的离子色谱法专属性强,精密度好,准确度高,可用于头孢噻吩钠中钠离子定量测定。8批样品的成盐状态良好。
OBJECTIVE: To establish a method for the determination of sodium ion in cefalotin sodium by ion chromatography and to investigate its salt-formation status. METHODS: The analytical column was TSKgel Super IC-CR cation column (150 mm × 4.6 mm, 3.0 μm) with a mobile phase of 2.2 mmol·L -1 and a mixture of methanesulfonic acid and 1 mmol·L-118 crown-6 ether Solution, flow rate of 0.8 ml · min-1, column temperature of 40 ℃, the injection volume of 20μl. The detector is a conductivity detector. Results: The linearity of sodium ion in the range of 3.0-60.0 μg · ml-1 was good (r = 0.999 9). The average recovery was 99.8% (RSD = 0.8%, n = 9). The molar ratio of sodium ion to cefalotin in the sample ranged from 0.97 to 1.03. Conclusion: The established ion chromatography has the advantages of high specificity, good precision and high accuracy, and can be used for the quantitative determination of sodium ion in cefalotin sodium. The salt formation of 8 batches of samples was good.