反相高效液相色谱法测定吸入用异丙托溴铵溶液的含量

RP-HPLC determination of content of ipratropium bromide solution for inhalation

目的:采用反相高效液相色谱法测定吸入用异丙托溴铵溶液的含量。方法:色谱柱为phenomenex-C_8(4.6mm×250mm,5μm),流动相为乙腈-0.25%庚烷磺酸钠溶液(29:71)用磷酸调pH值至3.2;检测波长为210 nm;流速为1.0 mL/min;进样量20μL。结果:异丙托溴铵在12.8～256.0μg/mL范围内与峰面积呈良好的线性关系,r=0.9995,日间、日内RSD均小于1.5%。结论:本方法准确可靠,可用于吸入用异丙托溴铵溶液的质量控制。

Objective： An RP-HPLC method was established for determination of content of ipratropinm bromide solution for inhalation. Methods： The chromatographic analysis was performed on a phenomenex-C8 column （4.6 mm × 250 mm, 5 μm）. The mobile phase consisted of acetonitrile- 0.25% 1-heptanesulfonic acid, sodium salt （pH was adjusted to 3.2 with phosphoric acid） （29：71）. The detection wavelength was at 210 nm. The flow rate was 1.0 mL·min^-1, with injection volume 20 μL. Results： There was a good linear relationship within the range of 12.8 - 256.0 μg·mL^-1 （ r = 0. 9995）. The reproducibility and precise of method was good. Conclusions： This method is accurate, specific and can be used for the quality control of ipratropinm bromide solution for inhalation.