目的：建立毛细管区带电泳法测定盐酸雷尼替丁注射液的含量和有关物质。方法：采用扩展光程（鼓泡检测池）未涂渍熔融石英毛细管（有效长度：56 cm；内径：75 μm；鼓泡因子：2.7）；以柠檬酸三钠-柠檬酸缓冲液（30 mmol·L-1，pH 5.5）为运行缓冲液；压力进样：3.0 kPa（10 s）；操作电压：30 kV；检测波长：230 nm；毛细管柱温：25℃。结果：雷尼替丁在1.015~203.1 μg·mL-1（r=0.999 9，n=7）范围内线性关系良好，准确度为99.3%（RSD=3.3%；n=9），检出限为0.338 mg·mL-1，重复性和日间精密度分别为1.6%和1.0%。雷尼替丁与主要的杂质均能有效分离。主要杂质雷尼替丁有关物质A、B、C分别在0.789 3~157.9 μg·mL-1（r=0.999 9，n=8）、1.003~200.6 μg·mL-1（r=0.999 8，n=8）、1.005~201.0 μg·mL-1（r=0.999 7，n=8）范围内线性关系良好，相对校正因子分别为1.219、1.179、1.278，检出限分别为0.395 μg·mL-1、0.502 μg·mL-1、0.502 μg·mL-1，准确度分别为113.2%（RSD=2.9%；n=9）、107.5%（RSD=3.0%；n=9）、101.1%（RSD=2.8%；n=9）。结论：该方法具有简便、准确、经济的特点，可用于盐酸雷尼替丁注射液的含量和有关物质测定。
Objective: To establish a capillary zone electrophoresis method for simultaneous determination of content and related substances in ranitidine hydrochloride injection.Methods: The analysis was performed on an extended light path(Bubble Cell) bare fused-silica capillaries of 75 μm×56 cm(2.7 of bubble factor) with 30 mmol·L-1 tri-sodium citrate-citric acid buffer solution(pH 5.5).The pressure injection was 3.0 kPa for 3 s, the separation voltage was 30 kV and the wavelength of detection was 230 nm.The column temperature was at 25.Results: The linearity of the calibration curves for ranitidine was 1.015 μg·mL-1 -203.1 μg·mL-1(r=0.999 9, n=7) with 99.3%(RSD=3.3%, n=9) of accuracy.The LOD of ranitidine was 0.338 μg·mL-1, the RSD of the repeatability and the intermediate precision were 1.6% and 1.0%, respectively.Ranitidine and major impurities could be separated well.The linearity of the calibration curves for Ranitidine Related Compound A, Related Compound B and Related Compound C was 0.789 3 μg·mL-1-157.9 μg·mL-1(r=0.999 9, n=8), 1.003 μg·mL-1-200.6 μg·mL-1(r=0.999 8, n=8), 1.005 μg·mL-1-201.0 μg·mL-1(r=0.999 7, n=8), respectively.The relative correcting factor of the ranitidine related compound A, related compound B and related compound C was 1.219, 1.179 and 1.278, respectively, while LOD was found to be 0.395 mg·mL-1, 0.502 mg·mL-1, 0.502 mg·mL-1, and the RSD of average recovery was 113.2%(RSD=2.9%;n=9), 107.5%(RSD=3.0%;n=9), 101.1%(RSD=2.8%;n=9), respectively.Conclution: The method is simple, accurate, economic and suitable for the determination of content and related substances in ranitidine hydrochloride injection.
