Abu-Hassan Ahmed A, Ali Ramadan, Derayea Sayed M
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University, Assiut Branch Assiut 71524 Egypt
Department of Analytical Chemistry, Faculty of Pharmacy, Minia University Minia 61519 Egypt.
RSC Adv. 2020 Oct 23;10(64):38884-38889. doi: 10.1039/d0ra05162d. eCollection 2020 Oct 21.
The current study describes a new, sensitive, and economic protocol for milnacipran analysis. Milnacipran was introduced as a therapy for fibromyalgia and depression. It acts by unique and equal inhibition of noradrenaline and serotonin neurotransmitters reuptake. In the presence of 2-mercaptoethanol, the amino moiety of milnacipran condenses with -phthalaldehyde to generate isoindole fluorescent derivative. The isoindole product was measured at ( 338.5 nm, 433.5 nm) and condensation variables were strictly optimized. The fluorescence intensity of measurements was plotted milnacipran concentration to give a linearity range over 200-4000 ng mL. The proposed approach was fully validated by the directives of ICH guidelines and applied without any influence of combined excipient for milnacipran tablet analysis. Furthermore, the procedure was applied in spiked urine and plasma analysis with excellent percentage recovery.
当前的研究描述了一种用于米那普明分析的新的、灵敏且经济的方法。米那普明被引入作为纤维肌痛和抑郁症的一种治疗药物。它通过独特且同等程度地抑制去甲肾上腺素和5-羟色胺神经递质的再摄取来发挥作用。在2-巯基乙醇存在的情况下，米那普明的氨基部分与邻苯二甲醛缩合生成异吲哚荧光衍生物。在（338.5纳米，433.5纳米）处测量异吲哚产物，并严格优化缩合变量。将测量的荧光强度与米那普明浓度作图，得到200 - 4000纳克/毫升的线性范围。所提出的方法按照国际人用药品注册技术协调会（ICH）指南的指令进行了全面验证，并应用于米那普明片剂分析，不受混合辅料的任何影响。此外，该方法应用于加标尿液和血浆分析，回收率百分比极佳。
