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目的: 建立反相高效液相色谱法测定穿琥宁及其注射液的含量。方法: 采用μBondpak C18 色谱柱, 甲醇-水(70∶30) 为流动相,250 nm 为检测波长, 室温下对穿琥宁及其注射剂进行含量测定。结果: 能将穿琥宁及其主要杂质穿心莲内酯进行分离; 穿琥宁在25 ~400 μg·mL- 1 范围内, 峰面积与其浓度线性关系良好(r= 0-999 9) ; 样品平均回收率为100-6 % ; 日内精密度RSD 为1-08% (n = 5), 日间(10 d 内) 精密度RSD为2-06 % (n= 5) 。结论: 该法简便、快速、专属性强, 可以满足其原料和制剂的质量控制要求。
Objective: To establish an RP-HPLC method for the determination of chuanhuning and its injection. Methods: μBondpak C18 column was used with methanol-water (70:30) as the mobile phase and the detection wavelength was at 250 nm. Chuanhuning and its injection were determined at room temperature. Results: Andrographolide and its major impurity, andrographolide were separated. Chuanhuning had a good linearity (r = 0-999 9) with a peak area of 25 ~ 400 μg · mL-1. The average recovery rate was 100 -6%. The intra-day precision RSD was 1-08% (n = 5). The intra-day (within 10 days) RSD was 2-06% (n = 5). Conclusion: The method is simple, rapid and specific, which can meet the quality control requirements of raw materials and preparations.