Omar Mahmoud A, Nagy Dalia M, Halim Monica E
Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, Egypt.
Luminescence. 2018 Sep;33(6):1107-1112. doi: 10.1002/bio.3516. Epub 2018 Jul 3.
For the determination of heptaminol (HEP) in its authentic and dosage form as well as in human plasma, a new simple, sensitive and cheap fluorimetric method of analysis was developed and validated. The presented method is based on the reaction between aliphatic primary amino moiety present in HEP with ninhydrin and phenylacetaldehyde using Torell and Stenhagen buffer at pH 8.2 that yields a highly fluorescent derivative which after excitation at 390 nm showed a fluorescence emission at 464 nm. The effects of various experimental factors on both the development and stability of the fluorescent product was evaluated and optimized. In the concentration range (0.5-6.0 μg/ml), the constructed calibration curve was linear with a good correlation coefficient (0.9997) and the calculated limit of detection (LOD) and limit of quantitation (LOQ) were 0.14 and 0.43 respectively. The presented method was successfully applied for determination of Corasore® tablets and validated according to ICH guidelines.
为了测定庚胺醇（HEP）的原料药、剂型以及人血浆中的含量，开发并验证了一种新的简单、灵敏且廉价的荧光分析方法。所提出的方法基于HEP中存在的脂肪族伯氨基部分与茚三酮和苯乙醛在pH 8.2的托雷尔和斯滕哈根缓冲液中发生的反应，该反应产生一种高荧光衍生物，在390 nm激发后，在464 nm处显示荧光发射。评估并优化了各种实验因素对荧光产物形成和稳定性的影响。在浓度范围（0.5 - 6.0 μg/ml）内，构建的校准曲线呈线性，相关系数良好（0.9997），计算得到的检测限（LOD）和定量限（LOQ）分别为0.14和0.43。所提出的方法成功应用于Corasore®片剂的测定，并根据ICH指南进行了验证。
