Reverse engineering study of atomoxetine hydrochloride oral solution

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Author: Qian ZENG ¹ Xue-Ying WU ² Wei-Ting WANG ¹ Qi-Lin DUAN ²  Zhi-Jun HUANG ¹

Affiliation: 1. School of Chemistry, Chemical Engineering and Life Sciences, Wuhan University of Technology, Wuhan 430070, China 2. Jianmin Pharmaceutical Group Co.Ltd., Wuhan 430052, China

Keywords: Atomoxetine hydrochloride oral solution Reverse engineering Prescription study

DOI: 10.19960/j.issn.1005-0698.202305009

Reference: Qian ZENG, Xue-Ying WU, Wei-Ting WANG, Qi-Lin DUAN, Zhi-Jun HUANG.Reverse engineering study of atomoxetine hydrochloride oral solution[J].Yaowu Liuxingbingxue Zazhi,,2023, 32(5): 545-553.DOI: 10.19960/j.issn.1005-0698.202305009.[Article in Chinese]  Copied

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Abstract

Objective To determine the oral solution of atomoxetine hydrochloride prescription proportion by reverse engineering study.

Methods The contents of sodium benzoate, sorbitol and xy-litol in the reference preparation were determined by HPLC, the contents of sodium dihydrogen phos-phate and phosphoric acid were determined by spectrophotometry combined with pH detection. Other methods were used to determine the content of sucralose and the type and dosage of aromatics in the self-researched oral solution.

Results The 100 mL oral solution of atomoxetine hydrochloride contains 0.4 g of atomoxetine, 0.08 g of sodium benzoate, 3.3 g of sorbitol, 30.0 g of xylitol, 0.08 g of phosphoric acid, 1.3 g of sodium dihydrogen phosphate, 0.05 g of sucralose and 2.0 g of strawberry flavor. Conclu-sion Reverse engineering research can effectively analyze the prescription composition and consump-tion of atomoxetine hydrochloride oral solution. The quality of the prepared sample is basically the same as that of the reference preparation, and the quality is easy to control.

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