HPLC法测定盐酸莫西沙星氯化钠注射液中脱羧莫西沙星的含量

Determination of Decarboxylation Moxifloxacin in Moxifloxacin Hydrochlorideand Sodium Chloride Injection by HPLC

目的:建立高效液相色谱法,用于盐酸莫西沙星氯化钠注射液中脱羧莫西沙星的含量测定。方法:色谱柱为菲罗门Gemini-NX C_(18)(4.6 mm×250 mm,5μm),以1%三乙胺溶液(用磷酸调节pH值至2.5):甲醇=70:30为流动相;280 nm作为检测波长;流速1.0 m L/min;柱温40℃。结果:脱羧莫西沙星的进样浓度在0.217 5～1.087 5μg/m L(r=0.998 5)范围内呈良好的线性关系;重复性、稳定性试验的RSD均小于2.0%;平均回收率为102.79%,RSD为1.62%(n=9)。结论:该高效液相色谱法的准确度高、重复性好,可以用来测定盐酸莫西沙星氯化钠注射液中脱羧莫西沙星的含量。

Objective： To establish an HPLC method for the determination of Decarboxylation Moxifloxacin in Moxifloxacin Hydrochlorideand Sodium Chloride Injection. Method： The assay was performed on a PhenomenexGemini-NX C18 column （4.6 mm ×250 mm, 5 μm） and the column temperature was 40 ℃ ,the mobile phase consisted of 1% triethylamine solution （pH to 2.5 with phosphoric acid）：methanol-70：30, the flow rate was 1.0 mL/min, and the UV detection wavelength was setat 280 nm. Results： There was a good linear relationship between the concentration of Decarboxylation Moxifloxacin and peak area in the range of 0.217 5 - 1.087 5 μg/mL （r=0.998 5）. The RSDs of stability and repeatability tests 〈2.0%. The average recovery was 102.79% RSD-1.62% （n=9）. Conclusion： The established method was accurate, reproducible, can be used for the assay of Decarboxylation Moxifloxacin in Moxifloxacin Hydrochloride and Sodium Chloride Injection.