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目的:建立用HPLC法测定注射用甲磺酸左氧氟沙星中左氧氟沙星的含量。方法:采用Kromasil C_(18)柱(150 mm×4.6 mm,5μm),以己烷磺酸钠溶液(取己烷磺酸钠0.98 g,加入pH2.4的磷酸盐缓冲液(取磷酸二氢钾6.8 g,加水溶解并稀释至1 500 ml,用磷酸调节pH至2.4)1 000 ml)-甲醇(70:30)为流动相。检测波长293 nm。结果:左氧氟沙星在20.1~180.9μg·ml~(-1)浓度范围内,线性关系良好,r=0.999 9;平均回收率为99.7%,RSD=0.8%(n=9)。结论:方法简便快捷、准确可靠、重复性好。
OBJECTIVE: To establish a HPLC method for the determination of levofloxacin in levofloxacin mesylate for injection. METHODS: Kromasil C 18 column (150 mm × 4.6 mm, 5 μm) was used. Sodium hexanesulfonate solution (0.98 g of sodium hexanesulfonate solution was added to phosphate buffer solution (pH = 2.4) Potassium 6.8 g, dissolved in water and diluted to 1 500 ml, with phosphoric acid to adjust the pH to 2.4) 1 000 ml) - methanol (70:30) as the mobile phase. Detection wavelength of 293 nm. Results: Levofloxacin showed good linearity in the range of 20.1-180.9μg · ml -1, r = 0.999 9; the average recovery was 99.7% and RSD was 0.8% (n = 9). Conclusion: The method is simple, accurate, reliable and repeatable.