HPLC法测定盐酸莫西沙星氯化钠注射液中N-甲基莫西沙星含量

HPLC Determination of N-Methyl Moxifloxacin in Moxifloxacin Hydrochloride and Sodium Chloride Injection

目的:建立HPLC法测定盐酸莫西沙星氯化钠注射液中N-甲基莫西沙星含量的方法。方法:采用菲罗门Gemini-NX C_(18)色谱柱(4.6 mm×250 mm,5μm),流动相为1%三乙胺溶液(用磷酸调p H值至2.5)-甲醇(70∶30),检测波长为293 nm,柱温为40℃,流量为1.0 m L·min^(-1)。结果:在选定的色谱条件下,N-甲基莫西沙星可准确测定,方法学考察符合分析检测要求。结论:建立的方法灵敏度高,测定结果准确,可用于盐酸莫西沙星氯化钠注射液中N-甲基莫西沙星的含量测定。

Objective：To develop an HPLC method for the determination of N-Methyl Moxifloxacin in Moxifloxacin Hydrochloride and＆amp;nbsp;Sodium Chloride Injection.Methods：The assay was performed on a Phenomenex Gemini-NX C18 column （4.6 mm ×250 mm,5 μm） with 1%triethylamine solution（adjusted pH to 2.5 with phosphoric acid）-methanol（70∶30） as mobile phase at the flow rate of 1.0 mL · min^-1;The column temperature was 40 ℃and detected with UV 293 nm.Results：The assay of N-Methyl Moxifloxacin was deter-mined accurately under the selected HPLC conditions, and the methodological studies conformed to the requirements for analysis. Conclusion： The method can be used for the assay of N-Methyl Moxifloxacin in Moxifloxacin Hydrochloride and Sodium Chloride Injec-tion with high sensitivity,accurate and reliable results.