Nirogi Ramakrishna, Ajjala Devender Reddy, Aleti Raghupathi, Rayapati Lakshmiprasanna, Pantangi Hanumanth Rao, Boggavarapu Rajesh Kumar, Padala Naga Surya Prakash
Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Road - 5, Avenue - 7, Banjara Hills, Hyderabad 500034, India.
Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Road - 5, Avenue - 7, Banjara Hills, Hyderabad 500034, India.
J Pharm Biomed Anal. 2017 Oct 25;145:423-430. doi: 10.1016/j.jpba.2017.04.005. Epub 2017 Apr 14.
A sensitive and rapid LC-MS/MS method was developed and validated for the quantification of SUVN-502 and M1 of SUVN-502, a 5-HT receptor antagonist for the treatment of dementia associated with Alzheimer's disease. Following solid-phase extraction, SUVN-502 and M1 of SUVN-502 and IS were eluted with 10mM ammonium acetate (pH 4.0) and acetonitrile using a rapid gradient program on reverse phase column. Multiple reaction monitoring mode was used to monitor the respective transitions of m/z 478.2→377.7 for SUVN-502 and m/z 464.1→377.7 for M1 of SUVN-502. The assay exhibited a linear dynamic range of 10-10000pg/mL for SUVN-502 and 20-20000pg/mL for M1 of SUVN-502 in human plasma. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. The within batch accuracy and precision were within acceptable limits. All the other validation parameters were within the acceptable limits. The validated method was applied to analyze human plasma samples obtained from a human pharmacokinetic study consisting single and multiple ascending doses.
开发并验证了一种灵敏、快速的液相色谱-串联质谱法，用于定量测定SUVN-502及其代谢物M1，SUVN-502是一种用于治疗阿尔茨海默病相关痴呆的5-羟色胺受体拮抗剂。在固相萃取后，使用反相柱上的快速梯度程序，用10mM醋酸铵（pH 4.0）和乙腈洗脱SUVN-502及其代谢物M1和内标。采用多反应监测模式监测SUVN-502的m/z 478.2→377.7和SUVN-502代谢物M1的m/z 464.1→377.7的各自跃迁。该测定法在人血浆中对SUVN-502的线性动态范围为10-10000pg/mL，对SUVN-502代谢物M1的线性动态范围为
