UPLC-MS/MS法测定注射用埃索美拉唑钠的含量 点击下载
论文标题: UPLC-MS/MS法测定注射用埃索美拉唑钠的含量
英文标题:
中文摘要: 目的:采用超高效液相色谱串联质谱法(UPLC-MS/MS)测定注射用埃索美拉唑钠的含量。方法:UPLC色谱柱为ZORBAX Eclipse Plus C18,流动相为0.1%甲酸-甲醇(73 ∶ 27,V/V),流速为0.3 ml/min,柱温为35 ℃,分析时间为5 min,进样量为2 μl;离子化模式为正离子模式,离子源温度为150 ℃,毛细管电压为3.0 kV,锥孔电压为50 V,锥孔气流量为150 L/Hr,脱溶剂气温度为450 ℃,脱溶剂气流量为900 L/Hr,雾化气压力为7.0 Bar,母离子扫描范围为100~800 mz/mz,工作模式为多反应监测模式。结果: 埃索美拉唑的检测质量浓度线性范围为0.2~20.0 ng/ml(r=0.999 7);定量限为50 pg/ml;精密度、稳定性、重复性试验的RSD<2%;回收率为99.93%~100.05%(RSD=0.1%,n=9)。结论:该方法操作简便、结果准确,可用于测定注射用埃索美拉唑钠的含量。
英文摘要: OBJECTIVE: To establish a method for the content determination of Esomeprazole sodium for injection. METHODS: UPLC-MS/MS was performed. The column of ZORBAX Eclipse Plus C18 with 0.1% formic acid-methanol(73 ∶ 27,V/V) at a flow rate of 0.3 ml/min, column temperature was 35 ℃, analysis time was 5 min, injection volume was 2 μl; ionization mode was positive ion mode, ion source temperature was 150 ℃, capillary voltage was 3.0 kV, cone voltage was 50 V, cone flow was 150 L/Hr, desolvation temperature was 450 ℃, desolvation gas flow was 900 L/Hr, nebuliser pressure was 7.0 Bar, parent ion scan range was 100-800 mz/mz, working mode was multiple reaction monitoring mode. RESULTS: The linear range of esomeprazole was 0.2-20.0 ng/ml(r=0.999 7); the limit of quantitation was 50 pg/ml; RSDs of precision, stability and reproducibility tests were lower than 2%; recovery was 99.93%-100.05%(RSD=0.1%,n=9). CONCLUSIONS: The method is simple and accurate, and can be used for content determination of Esomeprazole sodium for injection.
期刊: 2016年第27卷第27期
作者: 张雪宁,张利敏,张静,周春华,张乾,候志飞
英文作者: ZHANG Xuening,ZHANG Limin,ZHANG Jing,ZHOU Chunhua,ZHANG Qian,HOU Zhifei
关键字: 注射用埃索美拉唑钠;含量测定;超高效液相色谱串联质谱法
KEYWORDS: Esomeprazole sodium for injection; Content determination; UPLC-MS/MS
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