HPLC法测定水杨酸洗耳液中多库酯钠的含量
目的为准确测定水杨酸洗耳液中多库酯钠的含量，建立适合其含量检测的高效液相色谱法。方法建立了以十八烷基硅烷键为色谱柱为基础的色谱方法，其中，乙腈-水-三乙胺（800:190:10）（用磷酸调pH值至7.0）为流动相，流速为1.0 mL min-1，柱温为30 ℃，检测波长为210 nm。结果方法专属性良好，多库酯钠在0.374 9 ~ 1.125 mg mL-1内与峰面积呈现良好线性关系（r = 0.999 5），加样回收率均在98.0% ~ 102.0%。结论本实验建立的方法简便易行，专属性强，准确度和耐用性均良好，可以作为水杨酸洗耳液中多库酯钠的质量控制方法。
OBJECTIVE To establish a high performance liquid chromatography (HPLC) method for the accurate determination of docusate sodium in salicylic acid ear wash solution. METHODS A chromatographic method based on octadecylsilane bond column was established, in which acetonitrile water triethylamine (800:190:10) (adjust the pH value to 7.0 with phosphoric acid) was used as the mobile phase, the flow rate was 1.0 mL min-1, the column temperature was 30 ℃, and the detection wavelength was 210 nm. RESULTS The specificity of the method was good. Docusate sodium showed a good linear relationship with the peak area in the range ofDetermination of Docusate Sodium in Salicylic Acid Ear Wash by HPLC 0.3749 ~ 1.125 mg mL-1 (r = 0.999 5), and the recovery rate was 98.0% ~ 102.0%. Conclusion The method established in this work is simple, specific, accurate and durable, and can be used for the quality control of docusate sodium in salicylic acid ear wash solution.
王生娟、张真庆、阴佳茹、王莉君
博瑞生物医药（苏州）股份有限公司苏州大学药学院，苏州 215000博瑞生物医药（苏州）股份有限公司博瑞生物医药（苏州）股份有限公司
药学医学研究方法
水杨酸洗耳液高效液相色谱法多库酯钠含量
salicylic acid ear washHPLCdocusate sodiumassay
王生娟,张真庆,阴佳茹,王莉君.HPLC法测定水杨酸洗耳液中多库酯钠的含量[EB/OL].(2025-05-29)[2025-06-01].http://www.paper.edu.cn/releasepaper/content/202505-166.点此复制
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