Development and Validation of a Near Infra-Red (NIR) Hand-held Spectrophotometric Method Using PCA Approaches and Chemometric Tools: Application for Qualitative and Quantitative Determination of Tadalafil Marketed in Kinshasa—D.R. Congo
[en] A hand-held NIR spectrophotometric method was developed, validated, and applied for the determination of tadalafil in tablets. The aim of our work was to develop analytical methods based on vibrational techniques using low-cost portable equipment. Based on different chemometric modeling, we attempted to validate the method, which gave encouraging results from the principal component analysis (PCA), DD-SIMCA, and PLS modeling. Following this, we optimized the method using an appropriate experiment plan. For validation, we used the total error approach with acceptance limits set at ±10% with a risk level of 5%. The method showed that it was possible to perform both qualitative and quantitative analysis of pharmaceutical products using low-cost portable NIR systems with chemometric tools. The developed approach enabled the completion of the first step in implementing an NIR method for quality control of tadalafil-based drugs in the DRC. Validation difficulties of the PLS method resulted from the lack of information about inter-day serial variations of spectral responses. It would be interesting to extend the study to a larger calibration interval in order to correct uncertainties that may result from the variability observed under different conditions and to verify robustness. These are the limitations of this work, but the results are nevertheless very encouraging.
Research Center/Unit :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Mankulu Kakumba, Jocelyn ; Université de Liège - ULiège > Faculté de Médecine > Form. doct. sc. biomed. & pharma. (paysage) ; Laboratory of Drug Analysis and Health Products, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Pharmaceutical Organic and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Ciza Hamuli, Patient ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM) ; Laboratory of Drug Analysis and Health Products, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Luyinama, Merdie Mpemba; Laboratory of Drug Analysis and Health Products, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Kasago, Freddy Mugisho; Laboratory of Pharmaceutical Organic and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Tembo Monyele, Malachie; Laboratory of Drug Analysis and Health Products, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Ive Kitenge, Dadit ; Laboratory of Drug Analysis and Health Products, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Bayebila Menanzambi, Trésor ; Université de Liège - ULiège > Faculté de Médecine > Form. doct. sc. biomed. & pharma. (paysage) ; Laboratory of Drug Analysis and Health Products, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Kimbeni Malongo, Trésor; Laboratory of Drug Analysis and Health Products, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Pharmaceutical Organic and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Mana Kialengila, Didi; Laboratory of Pharmaceutical Organic and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Mbinze Kindenge, Jérémie; Laboratory of Drug Analysis and Health Products, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Pharmaceutical Organic and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo ; Laboratory of Drug Analysis and Diets Control, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Congo
Language :
English
Title :
Development and Validation of a Near Infra-Red (NIR) Hand-held Spectrophotometric Method Using PCA Approaches and Chemometric Tools: Application for Qualitative and Quantitative Determination of Tadalafil Marketed in Kinshasa—D.R. Congo
