Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Development and Validation of a Hand Held Spectrophotometric Method by Near Infra-Red (NIR) using PCA Approaches and Chemometric Tools: Application for Qualitative and Quantitative Determination of Tadalafil Marketed in Kinshasa-D.R. Congo

Jocelyn Mankulu Kakumba
* ORCID logo ,
Patient Hamuli Ciza
,
Merdie Luyinama Mpemba
,
Freddy Kasago Mugisho
,
Malachie Tembo Monyele
,
Dadit Ive Kitenge
,
Tresor Bayebila Menanzambi
,
Tresor Kimbeni Malongo
,
Didi Mana Kialengila
,
Jeremie Mbinze Kindenge
Version 1 : Received: 3 March 2024 / Approved: 4 March 2024 / Online: 4 March 2024 (19:15:05 CET)

How to cite: Mankulu Kakumba, J.; Ciza, P.H.; Mpemba, M.L.; Mugisho, F.K.; Tembo Monyele, M.; Ive Kitenge, D.; Bayebila Menanzambi, T.; Kimbeni Malongo, T.; Mana Kialengila, D.; Mbinze Kindenge, J. Development and Validation of a Hand Held Spectrophotometric Method by Near Infra-Red (NIR) using PCA Approaches and Chemometric Tools: Application for Qualitative and Quantitative Determination of Tadalafil Marketed in Kinshasa-D.R. Congo. Preprints 2024, 2024030190. https://doi.org/10.20944/preprints202403.0190.v1 Mankulu Kakumba, J.; Ciza, P.H.; Mpemba, M.L.; Mugisho, F.K.; Tembo Monyele, M.; Ive Kitenge, D.; Bayebila Menanzambi, T.; Kimbeni Malongo, T.; Mana Kialengila, D.; Mbinze Kindenge, J. Development and Validation of a Hand Held Spectrophotometric Method by Near Infra-Red (NIR) using PCA Approaches and Chemometric Tools: Application for Qualitative and Quantitative Determination of Tadalafil Marketed in Kinshasa-D.R. Congo. Preprints 2024, 2024030190. https://doi.org/10.20944/preprints202403.0190.v1

Abstract

A handheld NIR spectrophotometric method was developed, validated and applied for determination of tadalafil in tablets. The aim of our work was to develop analytical methods based on vibrational techniques and using low-cost portable equipment. Based on different chemometric modeling, we attempt to validate the method, that gave encouraging results from the principal component analysis (PCA), DD-SIMCA and PLS modeling. Then came optimization 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 to cross the first step in implementing a NIR method for quality control of Tadalafil-based drugs in the DRC. Validation difficulties of PLS method resulted from the lack of information about inter-days serial variations of spectral responses. This 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.

Keywords

Substandard and falsified medicines; Handheld NIR; Chemometric tools; Development; Validation

Subject

Chemistry and Materials Science, Analytical Chemistry

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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