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呋塞米片质量标准提高研究

         

摘要

目的 建立测定呋塞米片含量的超高效液相色谱(UHPLC)法.方法 采用Shim-pack XR-ODSⅢC18柱,以水-四氢呋喃-冰醋酸(63:37:1)为流动相,检测波长为272 nm,流速为0.2 mL/min.结果 回归方程为Y=6.92×106 X-2.88×104,r=0.9999(n=6),进样量线性范围为0.019~0.761μg,平均回收率为100.90%,RSD为1.56%(n=6).结论 UHPLC法在不影响分离效果的情况下可大大提高分析速度,改善分析效果,可以作为呋塞米片的质量控制标准.%Objective To establish a UHPLC method for quantity determination of Furosemide Tablets. Methods Shim-pack XR-ODSⅢ C18 column was adopted. The mobile phase consisted of water-tetrahydrofuran-glacial acetic acid (63 :37 :1),the detection wavelength was 272 nm and the flow rate was 0. 2 mL/min. Results The regression equation was Y=6. 92 × 106 X-2. 88 × 104,and the furosemide concentration was linear in the range of 0. 019-0. 761 μg (r=0. 9999),the average recovery was 100. 90%,RSD was 1. 56%(n=6). Conclusion The UHPLC method can increase the analysis speed and improve analysis effect on the condition that separation effect had not been influenced. which can be used as one of the quality control measures for Furosemide Tablets.

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