Method for detecting atomoxetine hydrochloride enantiomer by reversed-phase liquid chromatography

Abstract

The invention discloses a method for detecting atomoxetine hydrochloride enantiomer by reversed-phase liquid chromatography, which belongs to the field of pharmaceutical analysis, and adopts a polysaccharide derivative reversed-phase coating type chiral chromatographic column of which the surface of silica gel is coated with cellulose-tri (4-methyl benzoate) as a filler; and a mixed solution of a potassium hexafluorophosphate solution and acetonitrile is used as a mobile phase, the column temperature is 25-35 DEG C, the flow velocity is 0.5-0.8 ml / min, an ultraviolet detector is adopted, and the wavelength is 200-250 nm. According to the present invention, the atomoxetine hydrochloride and the enantiomer can be directly and effectively separated, the accuracy of the detection result is good, the sensitivity is high, and compared with the existing normal phase chromatography or precolumn derivatization reverse chromatography, the operation is simple, the cost is low, and the analysis time is short, such that the good guarantee is provided for the quality control of the atomoxetine hydrochloride and the preparation thereof.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for analyzing and determining atomoxetine hydrochloride enantiomers by reversed-phase liquid chromatography. Background technique [0002] Atomoxetine hydrochloride (Atomoxetine hydrochloride) is a selective norepinephrine reuptake inhibitor (SNRI), developed by Eli Lilly Company of the United States. The drug was officially approved by the FDA in July 2002 and was successfully marketed in 2003. It is the first non-central stimulant approved by the US FDA for the treatment of attention deficit disorder with hyperactivity (ADHD); it can prolong the release in the synaptic cleft The activity of norepinephrine is mainly used in the treatment of ADHD in adults and children over 7 years old. A number of studies at home and abroad have shown that atomoxetine hydrochloride has significant clinical efficacy, high patient compliance, and safe application. [0003] The chemical name...

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Problems solved by technology

[0007] Through reviewing Chinese and foreign literature and patents, it is found that there are relevant literature reports on the determination of atomoxetine hydrochloride enantiomers by high performance liquid phase method, most of which use normal phase HPLC system, and some use reversed phase chromatography system combined with evaporative light scattering detection For example, in "Examination of Related Substances of Atomoxetine Hydrochloride L-Isomer by HPLC", Chen Jie et al. used methanol-isopropanol-triethylamine (960:40:0.5) as the mobile phase, and the temperature of the drift tube must reach 90 ℃, higher requirements for instruments and equipment; others need to be derivatized before detection, such as "Pre-column Derivatization High Performance Liquid Chromatography Determination of S-Isomer Impurity Content in Atomoxetine Hydrochloride" Zhang Xiaoyan, etc. A method for the determination of isomer impurities in atomoxetine hydrochloride by pre-column derivatization reversed-phase high-performance liquid chromatography was established. The sensitivity of this method is 0.25 μg / ml, the detection limit is 0.08 μg / ml, and the operation is complicated , which is not conducive to the company's control of product quality

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