Determination of the quality of metronidazole formulations by near-infrared spectrophotometric analysis

Sakira, Abdoul Karim; Mees, Corenthin; Braekeleer, Kris De; Delporte, Cédric; Yameogo, Josias; Yabré, Moussa; Somé, Touridomon Issa; Antwerpen, Pierre Van; Mertens, Dominique; Kauffmann, J.M.

doi:10.1016/j.talo.2020.100027

Cited by 10 publications

(9 citation statements)

References 36 publications

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“…It allows the exploration of data through the reduction of its dimensionality [ 23 ]. In fact, PCA allows to reduce the dimensions of the original data space by using a smaller and more efficient abstract space of latent variables called principal components (PCs) [ 24 ]. In this new space, data (spectra in our case) can be displayed while keeping the same information as the original space.…”

Section: Methodsmentioning

confidence: 99%

“…(1) Classical SIMCA Analysis . The classical SIMCA algorithm uses samples with known origin (training samples) to perform a classification rule which allows classifying new samples (test samples) in one of the classes [ 24 ]. The different classes are modelled individually by a separate PCA.…”

Section: Methodsmentioning

confidence: 99%

“…Then, the results of PCA decomposition are used to compute a score distance ( hi ) and an orthogonal distance ( vi ) for each training sample [ 25 , 28 ]. Each type of distance is modelled using a scaled chi-squared distribution instead of the residual Q or Hotelling T2 statistics used in the original SIMCA models [ 24 ]. The calculated score and orthogonal distances are used to define the acceptance area or thresholds for the target class at a given significance level α .…”

Section: Methodsmentioning

confidence: 99%

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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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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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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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“…17,18 Metronidazole is an antibiotic and antiparasitic substance member of the nitroimidazole class, widely used in the treatment of a number of infections caused by anaerobic bacteria and some types of protozoa. 19 These two medicines were selected because they are on the national list of essential medicines in Cameroon 20 and have been listed among the most readily available on the African pharmaceutical market in two studies conducted in Cameroon, the Democratic Republic of Congo (DRC), and Togo. 21,22 The galenic tablet form was chosen because it represents the most often sold formulation and is in turn highly targeted by falsifiers.…”

Section: Introductionmentioning

confidence: 99%

Prevalence of Poor Quality Ciprofloxacin and Metronidazole Tablets in Three Cities in Cameroon

Tchounga

Sacré

Hamuli

et al. 2023

The American Journal of Tropical Medicine and Hygiene

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Quality is one of the essential components of medicines and needs to be ensured to preserve the population’s health. This can be achieved through post-marketing quality control of medicines and is one of the most important duties of national regulatory authorities. In collaboration with the Cameroonian National Drug Quality Control and Valuation Laboratory, the decision was made to initiate a prevalence study to assess the quality of antiinfective medicines in Cameroon. A total of 150 samples of ciprofloxacin tablets and 142 samples of metronidazole tablets were collected from 76 licensed pharmacies and 75 informal vendors in three cities in Cameroon using a random strategy wherever possible and a mystery shopper approach. Three tests were carried out on each of the samples. Visual inspection allowed to find two falsified samples (0.7%) due to lack of information about the manufacturing company, and five more samples (1.7%) were deemed to be substandard due to flaws in the product. An additional 13 samples (4.5%) failed disintegration testing, and six (2.1%) others failed high-performance liquid chromatography assay testing due to insufficient active pharmaceutical ingredient (API) content. All samples were found to contain some API. A prevalence of 7.9% substandard or falsified (SF) medicines was found. Moreover, the prevalence of outlets selling SF medicines was greater in the informal sector (26.7%) than in the formal sector (2.6%). Although the prevalence of SF medicines found was low, efforts need to be made by national regulatory authorities to monitor the pharmaceutical market more closely.

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“…In the literature, the use of different techniques was reported for separation or quantitative MNZ detection in environmental and biological samples, human plasma, drugs, and food products. They include high-performance liquid chromatography [ 11 ], liquid chromatography-tandem mass spectrometric method (LC-MS/MS) [ 12 ], chemiluminescence [ 13 ] fluorescence [ 14 , 15 ], near-infrared spectrophotometry (NIRS) [ 16 ], spectrophotometry [ 17 , 18 , 19 ], voltammetry with chemically modified electrodes [ 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ].…”

Section: Introductionmentioning

confidence: 99%

Study on Metronidazole Acid-Base Behavior and Speciation with Ca2+ for Potential Applications in Natural Waters

et al. 2022

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Metronidazole (MNZ) is an antibiotic widely used for the treatment of various infectious diseases and as an effective pesticide agent for the cultivation of chickens and fish. Its high resistance to purification processes and biological activity has led to the classification of MNZ as an emerging contaminant. A speciation study, aimed to define the acid-base properties of MNZ and its interaction with Ca2+, commonly present in natural waters, is reported. The protonation constants of MNZ, as well as the formation constant value of Ca2+-MNZ species, were obtained by potentiometric titrations in an aqueous solution, using NaCl as background salt at different ionic strengths (0.15, 0.5, 1 mol L−1) and temperature (15, 25 and 37 °C) conditions. The acid-base behavior and the complexation with Ca2+ were also investigated by 1H NMR and UV-Vis titrations, with results in very good agreement with the potentiometric ones. The dependence of the formation constants on the ionic strength and temperature was also determined. The sequestering ability of MNZ towards Ca2+ was defined by the empirical parameter pL0.5 at different pH and temperature values. The speciation of MNZ simulating sea water conditions was calculated.

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Determination of the quality of metronidazole formulations by near-infrared spectrophotometric analysis

Cited by 10 publications

References 36 publications

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

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

Prevalence of Poor Quality Ciprofloxacin and Metronidazole Tablets in Three Cities in Cameroon

Study on Metronidazole Acid-Base Behavior and Speciation with Ca2+ for Potential Applications in Natural Waters

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