Benserazide hydrochloride

　　Benserazide hydrochloride: a white or off-white crystalline powder, readily soluble in water, slightly soluble in ethanol, and insoluble in acetone. It is a decarboxylase inhibitor.

　 　Pharmaceutical Analysis

　　Method Name: Determination of Benzerazide Hydrochloride—High-Performance Liquid Chromatography

　　Scope of application: This method employs high-performance liquid chromatography to determine the content of benserazide hydrochloride.

　　This method is applicable to benzserazine hydrochloride.

　　Method principle: Both the sample and the internal standard are prepared as solutions in the mobile phase, injected into a high-performance liquid chromatograph for chromatographic separation, and detected with a UV absorbance detector at 220 nm. The absorbance values of benzserazine hydrochloride (C10H15N3O5·HCl) and the internal standard dopamine hydrochloride are measured, and their respective concentrations are calculated.

　 　Reagents:

　　1. Methanol

　　2. Trifluoroacetic acid

　 　Instruments and Equipment:

　　 1. Instrument

　　1.1 High-Performance Liquid Chromatograph

　　1.2 Chromatographic Column

　　Octadecylsilane‑bonded silica is used as the stationary phase; the theoretical plate count, calculated based on the benzylhydrazine hydrochloride peak, shall be not less than 1000, and the resolution between the benzylhydrazine hydrochloride peak and the internal standard peak shall meet the specified requirements.

　　1.3 Ultraviolet Absorption Detector

　　2. Chromatographic Conditions

　　2.1 Mobile phase: Water, trifluoroacetic acid + methanol = 1000:1:20

　　2.2 Detection wavelength: 220 nm

　　2.3 Column temperature: Room temperature