a Department of Chemistry, Government Degree College , Rajampeta, Kadapa Dist., Andhra Pradesh , India.
Crit Rev Anal Chem. 2016 Nov;46(6):482-9. doi: 10.1080/10408347.2016.1153948. Epub 2016 Feb 23.
Modafinil is a synthetic molecule used for the treatment of narcolepsy. Narcolepsy is a neurological disorder, due to which people experience frequent excessive daytime sleepiness (EDS). Nevertheless, there are some concerns about modafnil quality control. The modafinil enantiomers are both biologically active. However, it has been reported that the pharmacological properties of the both enantiomers are different and that the S-enantiomer is eliminated three times faster than the R-enantiomer. Therefore, most of the pharmaceutical companies have shifted to produce armodafinil (R-enantiomer) instead of the racemate. This article discusses about the critical review of the literature, the impact of the use of modafinil in the treatment of narcolepsy patients and other diseases, its physicochemical properties, toxicological properties, synthetic methods, analytical and bioanalytical methods and challenges that remain in order to ensure the quality. This article mainly focused on review of process related impurities, enantiomeric separation, metabolites of modafinil in various biofluids and pharmaceutical formulations using HPLC, LC-MS, GC-MS, CE, HPTLC and spectrophotometric methods.
莫达非尼是一种用于治疗嗜睡症的合成分子。嗜睡症是一种神经系统疾病，导致患者经常出现过度日间嗜睡（EDS）。然而，人们对莫达非尼的质量控制存在一些担忧。莫达非尼的对映异构体都具有生物活性。然而，据报道，两种对映异构体的药理学特性不同，S-对映异构体的消除速度比 R-对映异构体快三倍。因此，大多数制药公司已经转向生产阿莫达非尼（R-对映异构体）而不是外消旋体。本文讨论了文献的批判性评价，莫达非尼在治疗嗜睡症患者和其他疾病中的应用的影响，它的物理化学性质，毒理学性质，合成方法，分析和生物分析方法以及为了确保质量而仍然存在的挑战。本文主要集中于审查与过程相关的杂质、对映异构体分离、莫达非尼在各种生物流体和药物制剂中的代谢物，使用 HPLC、LC-MS、GC-MS、CE、HPTLC 和分光光度法。
