Application of High-Performance Thin Layer Chromatography and near Infrared Spectroscopy in the Validation of in-use Stability of Herbal Medicines used in the Management of Covid-19

Raphael J. Shedafa; Joseph Sempombe; Hamisi M Malebo; Joseph Otieno; Eliangiringa Kaale; Mary Temu; Peter Imming

Raphael J. Shedafa Department of Medicinal Chemistry, Muhimbili University of Health and Allied Sciences, Tanzania P.O. Box 65001, Dar es Salaam, Tanzania.
Joseph Sempombe Department of Medicinal Chemistry, Muhimbili University of Health and Allied Sciences, Tanzania P.O. Box 65001, Dar es Salaam, Tanzania.
Hamisi M Malebo UNESCO National Commission of the United Republic of Tanzania, 7 Magogoni Street, P.O. Box 20384, Dar es Salaam, Tanzania
Joseph Otieno Institute of Traditional Medicine-, Muhimbili University of Health and Allied Sciences, Tanzania P.O. Box 65001, Dar es Salaam, Tanzania.
Eliangiringa Kaale Pharm R&D Laboratory, School of Pharmacy, Muhimbili University of Health and Allied Sciences P.O. Box 65001, Dar es Salaam, Tanzania.
Mary Temu Department of Pharmaceutics, Muhimbili University of Health and Allied Sciences, Tanzania P.O. Box 65001, Dar es Salaam, Tanzania.
Peter Imming Institut fuer Pharmazie, Martin-Luther-Universitaet Halle-Wittenberg, 06120 Halle, Germany

Keywords: Covidol®, Rona®, in-use stability, stability-indicating HPTLC, NIRS, quality control

Abstract

Stability testing is a requirement in the registration process for all medicinal products, including herbal medicinal products (HMPs). This study was designed to investigate the stability of two herbal liquid preparations, Covidol® and Rona®, used to treat Covid-19 in Tanzania. The study aimed to predict the effect of standard environmental conditions on the in-use stability of liquid formulations of Covidol® and Rona® stored at ambient conditions for 28 days after opening. The chemical stability patterns of the two products were monitored using high-performance thin layer chromatography (HPTLC) and near infrared spectroscopy (NIRS) methods. Physical parameters such as pH, appearance and odor were also monitored. Under ambient conditions, Covidol® remained stable throughout the study period while Rona® underwent degradation as indicated by changes in its HPTLC and NIRS fingerprint patterns. These methods can be applied for quality control and stability testing of Covidol® and Rona® herbal products.