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目的:建立高效液相色谱法测定盐酸雷尼替丁注射液的含量。方法:色谱柱为Kromasil C_(18)(250 mm×4.6 mm,5μm),流动相为0.05 mol·L~(-1)柠檬酸溶液(用三乙胺调节pH至3.5)-乙腈(87:13),流速0.8 ml·min~(-1),检测波长314 nm,柱温30℃。结果:雷尼替丁在6.65~33.26μg·ml~(-1)的范围内线性关系良好(r=0.999 9),平均回收率为99.2%,RSD为0.4%。结论:本方法测定盐酸雷尼替丁注射液的含量简便、准确、专属性强。
Objective: To establish a HPLC method for the determination of ranitidine hydrochloride injection. METHODS: Kromasil C 18 column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of 0.05 mol·L -1 citric acid solution (adjusted to pH 3.5 with triethylamine) -acetonitrile (87: 13). The flow rate was 0.8 ml · min ~ (-1). The detection wavelength was 314 nm and the column temperature was 30 ℃. Results: Ranitidine showed good linearity (r = 0.999 9) in the range of 6.65 ~ 33.26μg · ml ~ (-1) with an average recovery of 99.2% and a RSD of 0.4%. Conclusion: The method for the determination of ranitidine hydrochloride injection content is simple, accurate and specific.