Vol 6 No 1 (2024)

Published: 2024-07-25

Abstract views: 666   PDF downloads: 106  
2024-07-29

Page 459-467

Phytochemical screening and GC-MS analysis of bioactive compounds present in methanolic extracts of 60 days old Nigerian Vigna Radiata leaves

blankpage Ebelechukwu C. Mmuta, Chimeebele A. Echekoba, Obioma S. Igwe, Josephat O. Ogbuagu, RoseMary U. Arinze, Okwuchukwu E. Onyekaonwu

Leaves of Vigna radiata (L.) are regarded as by-products due to the relatively low emphasis attributed to them when compared to the seeds and sprouts. They are usually left on the farm as waste products or for animals to graze on them, especially here in Nigeria; therefore, the need to investigate its various phytochemical content emerged, which will result in its optimum utilization. In the present study, 60 days old Vigna radiata (L.) leaves were harvested from V. radiata plants cultivated at the National Biotechnology and Research Development Centre Abagana, Anambra State, Nigeria. They were processed and milled into flour. Part of the milled flour was subjected to preliminary quantitative phytochemical screening, which revealed the presence of steroids as the major phytochemical content out of 12 bioactive compounds assessed with a value of 19.298%. The gas chromatography – mass spectrometry (GC-MS) used to determine the actual bioactive compounds present in the methanolic extracts of Nigerian V. radiata leaves (MENVrL) revealed the presence of 53 bioactive compounds with 58 peaks, covering a total peak area of 100% and these compounds were identified through spectrum matching with National Institute Standard and Technology (NIST) database. 2,4-Di-tert-butylphenol was identified as the major compound present in MENVrL  with a peak area of  7.66%. Further isolation of these bioactive compounds may prove the leaves a rich source of pharmaceutical, biological, and cosmetologically important raw materials, for the formulation of new effective drugs and other related products.

Abstract views: 671   PDF downloads: 219  
2024-07-25

Page 444-458

The clinical and regulatory status of NDSRI: A global imperative

blankpage Ritu Tiwari, Gaurav Sanjay Mahalpure, Sakshi Mahalpure, Anuanshika Tiwari

Detecting N-nitrosamine impurities in medicines has been a significant challenge for drug manufacturers and regulators, especially with the recent emergence of nitrosamine drug substance-related impurities (NDSRIs). The formation of NDSRIs is complex and primarily associated with reactions in the drug product. This paper explores the current technical knowledge on forming these impurities, including the risk factors, reaction conditions, and possible mitigation strategies. While significant scientific progress has been made in these areas, substantial gaps in mechanistic knowledge still make accurate predictions of NDSRI formation very difficult. The pharmaceutical industry's continued work on potential mitigation strategies and the generation of additional scientific data to address these knowledge gaps are crucial. Regulatory guidance and policy will continue to evolve in response to further changes in scientific understanding. In this article, we will delve into the detection methods, the mechanism of action, sample preparation techniques, and regulatory limits for nitrosamine impurities. We also discuss various reported nitrosamine impurities, their chemical structures, and their detection using methods like LC-MS/MS, GC-MS-HS, and HPLC. Additionally, we discuss different sample preparation techniques, such as solid-phase extraction, liquid-liquid extraction, and rapid-fire techniques. This review is intended to provide detailed information to analytical personnel working in various quality control laboratories and research organizations.