Ramadan Mai Abed Alrahman, Almasri Ihab, Khayal Ghada
Al-Azhar University-Gaza Faculty of Pharmacy, Department of Pharmaceutical Chemistry and Pharmacognosy, Gaza, Palestine.
Turk J Pharm Sci. 2020 Dec 23;17(6):679-685. doi: 10.4274/tjps.galenos.2019.25902.
Dopamine (DA) hydrochloride is a sympathomimetic agent used therapeutically for the correction of hemodynamic disorders associated with shock episodes. Although several analytical methods have been described, a spectroscopic assay of DA after chemical derivatization with 2,4-dinitrophenylhydrazine (DNP) is still unexamined. Therefore, the optimization of the reaction parameters and validation of developed method were required.
The method is based on coupling of DA as a phenolic compound with a diazonium salt to produce an intensely colored azo derivative. DNP was oxidized with potassium periodate to produce a diazonium salt that coupled with DA in basic media. The experimental parameters were then optimized. The developed method was validated according to International Conference on Harmonisation Guidelines and was applied to dosage forms. The results were compared with the data of a reference method.
The method was linear in a concentration range between 5 and 50 μg/mL. The regression line equation was Y=0.042±0.0003X+0.0672±0.0015 with a regression coefficient of 0.9944 (n=5). The limit of detection and limit of quantification were 0.32 and 0.97 μg/mL, respectively. The precision was satisfactory; the percentage relative standard deviation did not exceed 2%. The average values of the recovery study were in the range 98.90- 100.40±0.31-1.21%. The developed method was applied successfully for the determination of DA in injection and infusion fluid.
The method is accurate, sensitive, and practical for DA analysis in quality control laboratories.
盐酸多巴胺是一种拟交感神经药，用于治疗与休克发作相关的血流动力学紊乱。虽然已经描述了几种分析方法，但用2,4-二硝基苯肼（DNP）进行化学衍生化后对多巴胺的光谱测定仍未得到研究。因此，需要优化反应参数并验证所开发的方法。
该方法基于将作为酚类化合物的多巴胺与重氮盐偶联以产生颜色强烈的偶氮衍生物。用高碘酸钾将DNP氧化以产生重氮盐，该重氮盐在碱性介质中与多巴胺偶联。然后优化实验参数。根据国际协调会议指南对所开发的方法进行验证，并将其应用于剂型。将结果与参考方法的数据进行比较。
该方法在5至50μg/mL的浓度范围内呈线性。回归线方程为Y = 0.042±0.0003X + 0.0672±0.0015，回归系数为0.9944（n = 5）。检测限和定量限分别为0.32和0.97μg/mL。精密度令人满意；相对标准偏差百分比不超过2%。回收率研究的平均值在98.90 - 100.40±0.31 - 1.21%的范围内。所开发的方法成功应用于注射液和输液中多巴胺的测定。
该方法对于质量控制实验室中多巴胺的分析准确、灵敏且实用。
