PDF(Pubmed)
Abstract：
A novel antipsychotic medication named brexpiprazole (BRX) is currently employed for the treatment of schizophrenia and other psychotic disorders. Because BRX\'s molecular structure includes a benzothiophene ring, it natively fluoresces. To detect BRX with precision and speed, a flow injection-fluorometric method, which is both sensitive and selective, is recommended. The fluorescence detection was conducted at 364 nm following excitation at 326 nm to capture the strong intrinsic fluorescence of BRX. The carrier solution employed was a mixture of phosphate buffer (pH 4, 10 mM) and acetonitrile (50: 50, v/v), with a flow rate of 0.5 mL min- 1. The calibration curve, based on peak areas, exhibited linearity within the concentration range of 20-350 ng mL- 1, with a remarkable correlation coefficient (r2) of 0.9999. The limit of quantitation was 9.7 ng mL- 1, and the limit of detection was found to be 3.2 ng mL- 1. This method was applied to quantify BRX in Neopression® tablets, achieving recovery within an acceptable range without interference from the tablet\'s additives. Additionally, the proposed approach was successfully utilised to quantify the drug in spiked human plasma. The approach underwent validation following ICH requirements.
摘要：
一种名为brexpiprazole（BRX）的新型抗精神病药物目前用于治疗精神分裂症和其他精神病。因为BRX的分子结构包括苯并噻吩环，它本身发出荧光。检测BRX的精度和速度，流动注射荧光法，既敏感又有选择性，是推荐的。在326nm激发后在364nm进行荧光检测以捕获BRX的强固有荧光。使用的载体溶液是磷酸盐缓冲液(pH4,10mM)和乙腈(50:50,v/v)的混合物。流速为0.5mLmin-1。校正曲线,根据高峰面积，在20-350ngmL-1的浓度范围内呈线性关系，相关系数（r2）为0.9999。定量限为9.7ngmL-1，检测限为3.2ngmL-1。该方法用于量化Neopression®片剂中的BRX，在可接受的范围内实现回收率，而不受片剂添加剂的干扰。此外,所提出的方法已成功用于定量加标人血浆中的药物。该方法根据ICH要求进行了验证。
