Physicochemical variables and real time stability of the herbal substance of Niprd-AM1 - an antimalarial developed from the root of Nauclea latifolia S.M. (Rubiaceae)

The evidence for using the root of Nauclea latifolia S.M. (Rubiaceae) in treating malaria in Africa; and the development of Niprd AM1, as an antimalarial phytomedicine from it, are reviewed. This study aimed at paving the way for the registration and controlled production of Niprd-AM1, which was developed by National Institute for Pharmaceutical Research and development (NIPRD), Abuja, Nigeria.The study applied official procedures to authenticate and evaluate the changes that occur during normal storage in the physicochemical variables of the herb and extract.The herb contained alkaloids, saponins, terpenoids, but cardiac and cyanogenic glycosides and anthraquinones were not detected. Heavy metal presence was well below the limits allowed. Most of the quality variables evaluated, including TLCs, remained largely unchanged up to the 39 month of storage, but a few began to decline as from the 21st month.The results are consistent with NIPRD’s intention to regularize the production and use of Niprd-AM1 according to good pharmaceutical practice (GXP), and suggest that the dried herb and extract are stable under tropical room conditions for over a year in sealed glass containers. Keywords: Niprd-AM1; Nauclea latifolia; Antimalarial; Physicochemical; Stability; Good pharmaceutical practice (GXP).