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为有效分离分析舒他西林及其杂质在稳定性考察中的变化情况,利用ODS柱和腈基柱分别建立了2种反相离子对高效液相色谱分析系统,前者流动相为甲醇—四丁基氢氧化胺/三乙胺水溶液(含0.4%三乙胺的0.018mol/L四丁基氢氧化胺水溶液,用磷酸调pH4.0)=2872;后者为乙腈—四丁基氢氧化胺水溶液(0.005mol/L四丁基氢氧化胺水溶液,用磷酸调pH3.5)=199。ODS反相离子对色谱系统适合于准确测定稳定性考察中舒他西林含量的变化情况,而腈基柱反相离子对色谱系统则更适用于对舒他西林稳定性考察中诸相关物质的变化情况进行跟踪分析。利用建立的2种色谱系统,对舒他西林溶液的稳定性进行了考察,并对其水解过程进行了讨论。
In order to effectively separate and analyze the change of the stability of sultacillin and its impurities, two reversed-phase ion-pair HPLC systems were established by ODS column and nitrile column respectively. The mobile phase consisted of methanol-tetrabutyl hydrogen An amine oxide / triethylamine aqueous solution (0.018 mol / L tetrabutylammonium hydroxide aqueous solution containing 0.4% triethylamine, adjusted to pH 4.0 with phosphoric acid) = 2872; the latter was acetonitrile-tetrabutylammonium hydroxide aqueous solution .005mol / L tetrabutylammonium hydroxide aqueous solution, adjusted to pH3.5 with phosphoric acid = 199. The ODS reversed-phase ion-pair chromatography system is suitable for the accurate determination of the change in content of sultamicillin in the stability study whereas the nitrile-column reversed-phase ion-pair chromatography system is more suitable for the change of the related substances in the stability study of sultamicillin Follow-up analysis of the situation. The stability of sultamicillin solution was investigated by using two chromatographic systems established and the hydrolysis process was discussed.