Naraparaju Swathi, Yamjala Padmavathi, Chaganti Soujanya, Anumolu Durga Panikumar
Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Chemistry, Telangana, India.
Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Telangana, India.
Turk J Pharm Sci. 2024 Jan 19;20(6):405-411. doi: 10.4274/tjps.galenos.2022.09147.
A simple, sensitive, selective, and cost-effective colorimetric method has been established for the quantitative estimation of atomoxetine hydrochloride in bulk and formulation.A simple, sensitive, selective and cost effective colorimetric method has been entrenched for the quantitative estimation of Atomoxetine hydrochloride in bulk and formulation.
It was established based on the visible reaction between atomoxetine hydrochloride and 1,2-naphthoquinone-4-sulfonic acid sodium salt in a basic medium (potassium hydroxide). The resulting orange colored chromogen exhibited an absorption maximum at 474 nm.
Based on the optimization studies, distilled water as the solvent, 1% potassium hydroxide (2 mL), and 0.3% 1,2-naphthoquinone-4-sulfonic acid sodium salt (2 mL) were used in the method. The developed method was validated the International Council for Harmonization (ICH) guidelines. The linearity was found at a concentration of 10-50 μg/mL. The method showed a good correlation between the concentration of atomoxetine hydrochloride and its absorbance. The correlation coefficient (r) of 0.999 evidenced the same. The limits of detection and quantification were 0.20 and 0.606 μg/mL, respectively, for atomoxetine hydrochloride. The accuracy and precision of the method were also evaluated and the results obtained were within the acceptance criteria (relative standard deviation % < 2.00). The percentage assay of atomoxetine hydrochloride proved to be 101.52, which is in accordance with its label claim.
The developed method is non-complex and can be effectively employed in the analytical practices of atomoxetine hydrochloride in pharmaceutical dosage forms.
已建立一种简单、灵敏、选择性好且经济高效的比色法，用于定量测定原料药及制剂中盐酸托莫西汀的含量。已确立一种简单、灵敏、选择性好且经济高效的比色法，用于定量测定原料药及制剂中盐酸托莫西汀的含量。
该方法基于盐酸托莫西汀与1,2-萘醌-4-磺酸钠盐在碱性介质（氢氧化钾）中的可见反应。生成的橙色色原在474nm处有最大吸收。
基于优化研究，该方法使用蒸馏水作为溶剂、1%氢氧化钾（2mL）和0.3%1,2-萘醌-4-磺酸钠盐（2mL）。所建立的方法按照国际协调理事会（ICH）指南进行了验证。在10 - 50μg/mL的浓度范围内呈线性。该方法显示盐酸托莫西汀浓度与其吸光度之间具有良好的相关性。相关系数（r）为0.999证明了这一点。盐酸托莫西汀的检测限和定量限分别为0.20和0.606μg/mL。还对该方法的准确度和精密度进行了评估，所得结果在可接受标准范围内（相对标准偏差% < 2.00）。盐酸托莫西汀的含量测定百分比为101.52，符合其标签规定。
所建立的方法不复杂，可有效应用于药物剂型中盐酸托莫西汀的分析实践。
