Method for determining R isomer in dapoxetine hydrochloride

• Main Authors: YE HAIHONG, NIE WEI, CHEN DONGNI, WANG JIANSONG, GUO YUANLING, LI QIAOLING
• Format: Patent
• Language: Chinese; English
• Published: 27.05.2022
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention discloses a method for determining an R isomer in dapoxetine hydrochloride. The method comprises the following steps: determining the dapoxetine hydrochloride R isomer in a test solution by adopting a high performance liquid chromatography, a solvent used in the test solution is a mixed solution of normal hexane, ethanol and diethylamine; detection conditions in the high performance liquid chromatography are as follows: a chromatographic column is a cellulose chiral column; the column temperature is 20-30 DEG C; and the detection wavelength is 228 to 232 nm or 290 to 294 nm. According to the determination method, effective separation of the dapoxetine R isomer, the dapoxetine and other impurities can be achieved, the peak appearance time of the dapoxetine R isomer and the dapoxetine is early and is about 6-8 min, and the determination method has the advantages of being simple, rapid, high in accuracy and the like; the content of the dapoxetine R isomer can be accurately determined; the effective