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用于同时测定药物凝胶中抗组胺药盐酸曲吡那敏和苯海拉明的绿色胶束液相色谱法。

Green micellar liquid chromatographic method for simultaneous determination of antihistaminic drugs tripelennamine hydrochloride and diphenhydramine in pharmaceutical gel.

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, The Medical Campus of Tanta University, Tanta, Egypt.

出版信息

J Sep Sci. 2024 Jan;47(2):e2300757. doi: 10.1002/jssc.202300757.

Abstract

A new green micellar liquid chromatographic method has been developed and validated for the simultaneous determination of diphenhydramine (DPH) and tripelennamine hydrochloride (TRP) using a micellar mobile phase consisting of 1 mM Tween 20 in phosphate buffer pH 4:isopropanol (85:15, %v/v). The method was linear in the range of 4-150 and 5-120 μg/mL for TRP and DPH, respectively. The method was successfully applied for the simultaneous determination of DPH and TRP in a laboratory-prepared gel containing all possible excipients with mean percent recoveries ± standard deviation of 100.346 ± 1.265 and 100.754 ± 1.117 for TRP and DPH, respectively. The method was validated according to the International Conference on Harmonization guidelines. The method is confirmed to have excellent greenness.

摘要

建立并验证了一种新的胶束液相色谱法,用于同时测定盐酸曲普利啶(TRP)和苯海拉明(DPH)。该方法以胶束流动相(1mM Tween 20 的磷酸盐缓冲液 pH 4:异丙醇(85:15,%v/v))为基础。TRP 和 DPH 的线性范围分别为 4-150 和 5-120μg/mL。该方法成功地应用于实验室制备的凝胶中所有可能赋形剂的同时测定,TRP 和 DPH 的平均回收率(%)±标准偏差(%)分别为 100.346±1.265 和 100.754±1.117。该方法根据国际协调会议指南进行了验证。该方法被证实具有优异的绿色环保性。

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