高效液相色谱法测定注射用布美他尼含量

Determination of bumetanide for injection by HPLC

目的建立注射用布美他尼含量测定方法。方法采用高效液相色谱法。Kromasil ODS-1（5μm，4．6mm×200mm）为色谱柱；甲醇-水（60：40）（磷酸调pH值至2．5）为流动相，流速为1．0mL／min，检测波长为220nm。结果注射用布美他尼在0．013～0．13mg／mL的范围内，线形关系良好（r=0．9999），平均回收率为100．2％（RSD为0．90％）。结论建立的方法简便、准确、专属性好，可用于注射用布美他尼的质量控制。

OBJECTIVE To establish a method to determine the content of bumetanide for injection. METHODS An HPLC assay was developed. Chromatographic assay was performed on a Kromasil ODS-1 （5μm, 4.6×200mm） column using the mobile phase of methanol-water （60 ： 40, adjusted to pH2.5 with phosphoric acid） at the detective wavelength of 220 nm with the flow rate of 1.0mL/min. RESULTS The calibration curve was linear in the range of 0.013～0.13 mg/mL （r = 0.999 9）. The average was 100.2% with RSD of 0.90%. CONCLUSION The method had the advantage of simplicity, accuracy and reliability, and it may be used for the quantitative determination of bumetanide for injection.