Green Analytical Methods of Antimalarial Artemether-Lumefantrine Analysis for Falsification Detection Using a Low-Cost Handled NIR Spectrometer with DD-SIMCA and Drug Quantification by HPLC

Yabré, Moussa; Ferey, Ludivine; Sakira, Abdoul Karim; Bonmatin, Camille; Fauré, Clotilde; Somé, Touridomon Issa; Gaudin, Karen

doi:10.3390/molecules25153397

Cited by 13 publications

(6 citation statements)

References 32 publications

(40 reference statements)

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“…These results are similar to those of Ciza et al who found that the application of OCC models to NIR spectra allowed a good discrimination between samples containing different APIs [43]. Moreover, these findings are in accordance with those of Yabre et al who achieved 100% specificity with correct discrimination of falsified samples [5,44].…”

Section: Plos Onesupporting

confidence: 91%

“…The confirmatory phase implies the control of several quality attributes of the medicines as recommended by some specific monographies or validated methods such as the identification of the active pharmaceutical ingredient (API), its assay, a dissolution test, evaluation of the uniformity of dosage units, and the control of impurities (identification and/or quantification) [5]. Besides these usual tests, several specific tests may be required depending on the nature of the medicines, e.g., modified release tablets needs specific dissolution testing, parenteral preparations need sterility and endotoxin testing etc.…”

Section: Introductionmentioning

confidence: 99%

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Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance

et al. 2023

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The negative consequences of Substandard and falsified (SF) medicines are widely documented nowadays and there is still an urgent need to find them in more efficient ways. Several screening tools have been developed for this purpose recently. In this study, three screening tools were used on 292 samples of ciprofloxacin and metronidazole collected in Cameroon. Each sample was then analyzed by HPLC and disintegration tests. Seven additional samples from the nitro-imidazole (secnidazole, ornidazole, tinidazole) and the fluoroquinolone (levofloxacin, ofloxacin, norfloxacin, moxifloxacin) families were analyzed to mimic falsified medicines. Placebo samples that contained only inert excipients were also tested to mimic falsified samples without active pharmaceutical ingredient (API). The three screening tools implemented were: a simplified visual inspection checklist, a low-cost handheld near infrared (NIR) spectrophotometer and paper analytical devices (PADs). Overall, 61.1% of the samples that failed disintegration and assay tests also failed the visual inspection checklist test. For the handheld NIR, one-class classifier models were built to detect the presence of ciprofloxacin and metronidazole, respectively. The APIs were correctly identified in all the samples with sensitivities and specificities of 100%. However, the importance of a representative and up-to-date spectral database was underlined by comparing models built with different calibration set spanning different variability spaces. The PADs were used only on ciprofloxacin samples and detected the API in all samples in which the presence of ciprofloxacin was confirmed by HPLC. However, these PADs were not specific to ciprofloxacin since they reacted like ciprofloxacin to other fluoroquinolone compounds. The advantages and drawbacks of each screening tool were highlighted. They are promising means in the frame of early detection of SF medicines and they can increase the speed of decision about SF medicines in the context of pharmaceutical post-marketing surveillance.

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Section: Plos Onesupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance

et al. 2023

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“…Drug quality control is a key issue in the supply chain monitoring, law enforcement, and ensuring patient protection [ 9 ]. It is generally performed according to pharmacopeias which involved analytical techniques such as liquid or gas chromatography.…”

Section: Introductionmentioning

confidence: 99%

“…Besides their low cost, they can offer promising performance comparable to bench-top instruments [ 19 , 20 ]. Their potential has been assessed in the detection of falsified antimalarial artemether and lumefantrine drugs [ 9 , 19 ].…”

Section: Introductionmentioning

confidence: 99%

Detection of Falsified Antimalarial Sulfadoxine-Pyrimethamine and Dihydroartemisinin-Piperaquine Drugs Using a Low-Cost Handheld Near-Infrared Spectrometer

Yabré

Sakira

Bandé

et al. 2022

Journal of Analytical Methods in Chemistry

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Falsified drugs are of serious concern to public health worldwide, particularly for developing countries where quality control of drugs is inefficient. In law enforcement against such fake medicines, there is a need to develop reliable, fast, and inexpensive screening methods. In this work, the ability of an innovative low-cost handheld near-infrared spectrometer to identify falsifications among two antimalarial fixed dose combination tablets, dihydroartemisinin/piperaquine and sulfadoxine/pyrimethamine, has been investigated. Analyzed samples were collected in Burkina Faso mainly in rural transborder areas that could be infiltrated by illicit drugs. A principal component analysis was applied on the acquired near-infrared spectra to identify trends, similarities, and differences between collected samples. This allowed to detect some samples of dihydroartemisinin/piperaquine and sulfadoxine/pyrimethamine which seemed to be falsified. These suspicious samples were semiquantitatively analyzed by thin-layer chromatography using Minalab® kits. Obtained results allowed to confirm the falsifications since the suspected samples did not contain any of the expected active pharmaceutical ingredients. The capacity of the low-cost near-infrared device to identify specifically a brand name of dihydroartemisinin/piperaquine or sulfadoxine/pyrimethamine has been also studied using soft independent modelling of class analogy (SIMCA) in the classical and data driven versions. The built models allowed a clear brand identification with 100% of both sensitivity and specificity in the studied cases. All these results demonstrate the potential of these low-cost near-infrared spectrometers to be used as first line screening tools, particularly in resource limited laboratories, for the detection of falsified antimalarial drugs.

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“…[13][14][15] Although there are various portable analyzers that can be used in the field, Raman scattering analyzers are relatively higher cost, and this can inhibit their introduction in some areas, such as medical institutions and LMICs. [16][17][18][19][20][21][22][23] Therefore, we examined the application of an ultra-compact Raman scattering analyzer developed in Japan (C13560), which is a low-cost portable analyzer that can be used in the field.…”

Section: Introductionmentioning

confidence: 99%

Detection Method of Falsified Medicines by Using a Low-Cost Raman Scattering Spectrometer Combined with Soft Independent Modeling of Class Analogy and Partial Least Squares Discriminant Analysis

Sanada

Yoshida

Kimura

et al. 2021

Biological & Pharmaceutical Bulletin

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There are many reports of falsified medicines that may cause harm to patients. A rapid and simple method of identifying falsified medicines that could be used in the field is required. Although Raman scattering spectroscopy has become popular as a non-destructive analysis, few validation experiments on falsified medicines that are actually distributed on the market have been conducted. In this study, we validated a discriminant analysis using an ultra-compact, portable, and low-cost Raman scattering spectrometer combined with multivariate analysis. The medicines were three types of erectile dysfunction therapeutic tablet and one type of antifungal tablet: tadalafil (Cialis), vardenafil hydrochloride (Levitra), sildenafil citrate (Viagra), and fluconazole (Diflucan), which is sometimes advertised as female Viagra. For each medicine, the authentic standard product and products obtained by personal import via the internet (genuine or falsified) were used. Discriminant analyses were performed on the Raman spectra combined with soft independent modeling of class analogy (SIMCA) and partial least squares discriminant analysis (PLS-DA). It was possible to identify all falsified samples by SIMCA using the standard product model for all four products. Using the PLS-DA using the PLS models of the four standard products, falsified Levitra and Diflucan samples were classified correctly, although some falsified Cialis and all Viagra samples also belonged to the standard class. In this study, SIMCA might be more suitable than PLS-DA for identifying falsified medicines. A spectroscopic module that combines the low-cost Raman scattering spectroscopy with SIMCA might contribute to the rapid identification of falsified medicines in the field.

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Green Analytical Methods of Antimalarial Artemether-Lumefantrine Analysis for Falsification Detection Using a Low-Cost Handled NIR Spectrometer with DD-SIMCA and Drug Quantification by HPLC

Cited by 13 publications

References 32 publications

Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance

Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance

Detection of Falsified Antimalarial Sulfadoxine-Pyrimethamine and Dihydroartemisinin-Piperaquine Drugs Using a Low-Cost Handheld Near-Infrared Spectrometer

Detection Method of Falsified Medicines by Using a Low-Cost Raman Scattering Spectrometer Combined with Soft Independent Modeling of Class Analogy and Partial Least Squares Discriminant Analysis

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