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目的:测定阿莫西林-舒巴坦匹酯片的含量及有关物质。方法:反相离子对高效液相色谱法。色谱条件:ODS柱,流动相为0.01mol·L~(-1)SDS(pH 2.5)-甲醇(45:55),流速为1.0mL·min~(-1),检测波长230nm。结果:舒巴坦匹酯和阿莫西林的线性范围分别为11.0~0.125mg·mL~(-1)和0.25~0.015 mg·mL~(-1),回收率分别为98.9%和98.5%,RSD分别为1.5%和1.6%(n=5)。阿莫西林和舒巴坦匹酯的相对吸收系数比为19.6。结论:该方法能简单、快速、准确地同时测定阿莫西林和舒巴坦匹酯的含量和有关物质。
Objective: To determine the content of amoxicillin-sulbactam and its related substances. Methods: Reverse phase ion-pair high performance liquid chromatography. Chromatographic conditions: ODS column, the mobile phase was 0.01mol·L -1 SDS (pH 2.5) -methanol (45:55), the flow rate was 1.0mL · min -1, the detection wavelength was 230nm. Results: The linear ranges of sulbactam and amoxicillin were 11.0-0.125 mg · mL -1 and 0.25-0.015 mg · mL -1, respectively. The recoveries were 98.9% and 98.5%, respectively. The RSDs were 1.5% and 1.6%, respectively (n = 5). The relative absorption coefficient ratio of amoxicillin and sulbactam was 19.6. Conclusion: This method can be used to determine the content and related substances of amoxicillin and sulbactam in a simple, rapid and accurate manner.