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Green micellar liquid chromatographic method for simultaneous determination of antihistaminic drugs tripelennamine hydrochloride and diphenhydramine in pharmaceutical gel
Journal of Separation Science ( IF 3.1 ) Pub Date : 2024-01-28 , DOI: 10.1002/jssc.202300757
Sherin F. Hammad 1 , Samah F. El‐Malla 1 , Basma Z. El‐Khateeb 1
Affiliation  

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.

中文翻译:

绿色胶束液相色谱法同时测定药物凝胶中抗组胺药物盐酸曲吡那明和苯海拉明的含量

开发并验证了一种新的绿色胶束液相色谱方法,可使用由 1 mM Tween 20 溶于磷酸盐缓冲液 pH 4:异丙醇(85:15, %v/v)。该方法对于 TRP 和 DPH 分别在 4-150 和 5-120 μg/mL 范围内呈线性。该方法成功应用于实验室制备的含有所有可能的赋形剂的凝胶中的 DPH 和 TRP 的同时测定,TRP 和 DPH 的平均百分比回收率±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。证实该方法具有优良的绿色度。
更新日期:2024-01-29
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