目的 建立测定枸橼酸铋钾颗粒、胶囊、片中枸橼酸的阴离子交换色谱法。方法 采用Dionex IonPac^TM AS11-HC色谱柱（250 mm×4 mm）和AS11-HC保护柱（50 mm×4 mm）；淋洗液为35 mmol/L氢氧化钾溶液；体积流量为1.0 mL/min；抑制器抑制电流为87 mA；电导检测器；柱温为30 ℃；检测器温度为35 ℃；进样体积为25 μL。结果 枸橼酸在11.60～116.00 μg/mL与峰面积线性关系良好（r＝0.999 9），平均回收率为99.76%，RSD值为1.39%（n＝9）。结论 所建立的方法线性关系良好，专属性、精密度、稳定性、重复性佳，可用于枸橼酸铋钾制剂的质量控制。

Objective To establish an anion exchange chromatography method for the determination of citric acid in Bismuth Potassium Citrate Granules, Capsules, and Tablets. Methods The analytical column was Dionex IonPac^TM AS11-HC column (250 mm × 4 mm), and the guard column was AS11-HC column (50 mm × 4 mm). The eluent was 35 mmol/L potassium hydroxide solution, the flow rate was 1.0 mL/min, the suppression current of the suppressor was 87 mA, the conductivity detector was used, the column temperature was 30 ℃, the detector temperature was 35 ℃, and the injection volume was 25 μL. Results There was a good linear relationship between the concentration of citric acid and the peak area in the range of 11.60 — 116.00 μg/mL (r = 0.999 9). The average recovery rate of citric acid was 99.76%, and the RSD value was 1.39% (n = 9). Conclusion The established method exhibits excellent linearity, specificity, precision, stability, and repeatability, which be suitable for the quality control for bismuth potassium citrate preparations.

R927.1

江苏省药品抽检计划项目（苏药监稽【2024】33号）