Ragab Marwa A A, Abdel-Hay Mohamed H, Ahmed Hytham M, Mohyeldin Sara M
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Alexandria University, El‑Messalah, Alexandria, Egypt.
Pharmaceutical Analysis Department, Faculty of Pharmacy, Menoufia University, Shebin El-Kom, Menoufia, Egypt.
J Chromatogr Sci. 2019 Aug 1;57(7):592-599. doi: 10.1093/chromsci/bmz031.
Two chromatographic methods (high performance thin layer chromatography (HPTLC) and high performance liquid chromatography-diode array detector (HPLC-DAD)), were addressed for the analysis of a mixture consisted of phenylephrine hydrochloride and ibuprofen in two forms bulk and their combined dosage form. This binary mixture is considered to be a challenging one as the two drugs differ greatly in their chemical and physical properties. Not only this affects their simultaneous analysis, but also hinders their simultaneous extraction from biological fluids as plasma. That is the reason the literature lacks any report for the simultaneous extraction and analysis of these drugs from biological fluids. The concentration ranges of both drugs were 0.1-2.5 μg/spot and 0.1-100 μg/mL by HPTLC and HPLC, respectively. Not only was the HPLC-DAD method applied to the investigated drugs determination in pharmaceutical preparations, but also in spiked human plasma. Extensive study was conducted to optimize their simultaneous extraction from plasma as it was a crucial step for the in vivo analysis. The results obtained by proposed methods and a reference one were statistically comparable by analysis of variance test. No significant difference was recorded between the mean percent levels determined by the proposed methods and the reference one.
研究了两种色谱方法（高效薄层色谱法（HPTLC）和高效液相色谱 - 二极管阵列检测器法（HPLC - DAD）），用于分析由盐酸去氧肾上腺素和两种形式（原料药及其复方制剂）的布洛芬组成的混合物。这种二元混合物被认为具有挑战性，因为这两种药物在化学和物理性质上有很大差异。这不仅影响它们的同时分析，还阻碍它们从生物流体（如血浆）中的同时提取。这就是文献中缺乏关于从生物流体中同时提取和分析这些药物的任何报告的原因。通过HPTLC和HPLC测定的两种药物的浓度范围分别为0.1 - 2.5μg/斑点和0.1 - 100μg/mL。HPLC - DAD方法不仅应用于药物制剂中所研究药物的测定，还应用于加标的人血浆中。进行了广泛的研究以优化它们从血浆中的同时提取，因为这是体内分析的关键步骤。通过方差分析测试，所提出的方法和参考方法获得的结果在统计学上具有可比性。所提出的方法和参考方法测定的平均百分比水平之间没有记录到显著差异。
