Zaafan Al Amir S, Elhamdy Hadeer A
Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Sohag University, Sohag, 82524, Egypt.
BMC Chem. 2025 Mar 8;19(1):62. doi: 10.1186/s13065-025-01428-y.
Straightforward, eco-friendly, quick, and sensitive spectrophotometric procedures were created and proven to be effective for determining the amount of duloxetine and amitriptyline in bulk and pharmaceutical dosage forms. The basis of the suggested procedures was the formation of an ion association complex in an aqueous buffered solution containing duloxetine and amitriptyline with eosin Y. The resulting compound displayed absorption peaks at 546 nm under optimum circumstances. With a linear relationship and a good correlation value of 0.9996 for DLX and 0.9997 for AMT, the calibration plots were rectilinear over the concentration range of 0.5-8 µg mL for DLX and 1-7 µg mL for AMT. The quantitation limits were 0.48 and 0.49 µg mL for DLX and AMT, respectively, whereas the detection limits were 0.16 µg mL for both drugs. The research process has been optimized with respect to the many experimental parameters. The approaches were assessed in accordance with ICH guidelines. The suggested approaches were successfully used to analyze pharmaceutical formulations, including the cited medications. Additionally, the recommended methods performed admirably when used to assess content uniformity. The proposed method is highly green as water was used as the solvent. Utilizing four metric tools called the NEMI, Eco-Scale, GAPI, and AGREE, the established techniques' environmental impact was assessed. Also, the practicality (blueness) of procedures was assessed using a recently developed metric called the Blue Applicability Grade Index (BAGI).
已创建并证明了直接、环保、快速且灵敏的分光光度法程序,可有效测定散装和药物剂型中度洛西汀和阿米替林的含量。所建议程序的基础是在含有度洛西汀和阿米替林的水性缓冲溶液中与曙红Y形成离子缔合络合物。在最佳条件下,所得化合物在546 nm处显示吸收峰。校准曲线在度洛西汀浓度范围为0.5 - 8 μg/mL和阿米替林浓度范围为1 - 7 μg/mL时呈线性关系,度洛西汀的相关系数为0.9996,阿米替林的相关系数为0.9997。度洛西汀和阿米替林的定量限分别为0.48和0.49 μg/mL,而两种药物的检测限均为0.16 μg/mL。针对许多实验参数对研究过程进行了优化。这些方法按照国际人用药品注册技术协调会(ICH)指南进行了评估。所建议的方法成功用于分析药物制剂,包括上述药物。此外,所推荐的方法在用于评估含量均匀度时表现出色。所提出的方法具有高度的绿色环保性,因为使用水作为溶剂。利用称为NEMI、生态尺度、GAPI和AGREE的四种度量工具评估了既定技术的环境影响。此外,使用最近开发的称为蓝色适用性等级指数(BAGI)的度量评估了程序的实用性(蓝色度)。