Method for determining particle size of dapagliflozin bulk drug

• Main Authors: SHAO FANG, LI QINGYAN, WANG CHUANXU, LIANG QIANNAN, SONG GENGSHEN
• Format: Patent
• Language: Chinese; English
• Published: 25.06.2024
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention relates to the technical field of pharmaceutical analysis or preparations, and discloses a dapagliflozin bulk drug particle size determination method, which comprises: (1) dispersing a dapagliflozin bulk drug in a dispersion medium, and carrying out first ultrasonic treatment in an ultrasonic instrument; and (2) carrying out second ultrasonic treatment on the raw material medicines obtained in the step (1) in ultrasonic equipment of a sample injector, and then carrying out a wet laser particle size test. According to the method for determining the particle size of the dapagliflozin bulk drug, by optimizing parameters such as the stirring speed and the ultrasonic time, the determination method which is good in repeatability and high in precision is established, and the control requirements of pharmacopeia on particle size determination are met. 本发明涉及药物分析或制剂技术领域，公开了达格列净原料药粒径测定的方法，测定步骤如下：(1)取达格列净原料药分散于分散介质中，并在超声仪中进行第一超声；(2)将步骤(1)所得原料药物料，在进样器超声设备中进行第二超声之后，再进行湿法激光粒度测试。上述达格列净原料药的粒径测定方法，通过对搅拌速度，超声时间等参数