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 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.

Published
2023-04-26
How to Cite
Shedafa, R., Sempombe, J., Malebo, H., Otieno, J., Kaale, E., Temu, M., & Imming, P. (2023). 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. The East and Central African Journal of Pharmaceutical Sciences, 25(1), 31-40. Retrieved from https://uonjournals.uonbi.ac.ke/ojs/index.php/ecajps/article/view/1483