The greening of analytical methods has gained increasing interest in the field of pharmaceutical analysis to reduce environmental impacts and improve the health safety of analysts. Reversed-phase ...high-performance liquid chromatography (RP-HPLC) is the most widely used analytical technique involved in pharmaceutical drug development and manufacturing, such as the quality control of bulk drugs and pharmaceutical formulations, as well as the analysis of drugs in biological samples. However, RP-HPLC methods commonly use large amounts of organic solvents and generate high quantities of waste to be disposed, leading to some issues in terms of ecological impact and operator safety. In this context, greening HPLC methods is becoming highly desirable. One strategy to reduce the impact of hazardous solvents is to replace classically used organic solvents (i.e., acetonitrile and methanol) with greener ones. So far, ethanol has been the most often used alternative organic solvent. Others strategies have followed, such as the use of totally aqueous mobile phases, micellar liquid chromatography, and ionic liquids. These approaches have been well developed, as they do not require equipment investments and are rather economical. This review describes and critically discusses the recent advances in greening RP-HPLC methods dedicated to pharmaceutical analysis based on the use of alternative solvents.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Mercury (II) measurements were performed thanks to a newly developed electrochemical method using a disposable gold modified screen printed carbon electrode. The method has a wide dynamic range ...(1–100µg/L), a good accuracy and a limit of detection in compliance with WHO standards. The application of the method to several groundwater samples made it possible to identify, for the first time, mercury content higher than the recommended WHO standard value in a gold mining activity area in the northern part of Burkina Faso. The accuracy of the assay was checked by ICP/MS.
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•Disposable voltammetric sensor selective and highly sensitive to mercuric ions.•Determination of mercury (II) content in groundwater in Burkina Faso mining area.•Discovery of one sample of groundwater with mercury content five times higher than WHO guidelines.•Possible application of the developed sensor for on-site experiments.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
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•Single, green and robust RP-HPLC method was established for analysis of impurities.•Artesunate and amodiaquine drugs and their impurities analyzed with green RP-HPLC.•Ethanol was ...used as green solvent for related substance quantitative analysis.•QbD was combined with Green Chemistry principles for pharmaceutical analysis.•Method was validated by total error approach and applied to raw material and tablet.
Greening analytical methods has become of great interest in the field of pharmaceutical analysis to protect both the operators’ health and the environment. In this work, an innovative methodology combining Quality-by-Design (QbD) and Green Chemistry principles was followed to develop a single, green and robust RP-HPLC method for the quantitative analysis of impurities of both artesunate and amodiaquine drugs. Ethanol was selected as the best ecofriendly alternative solvent in substitution to the commonly used organic solvents such as acetonitrile and methanol. To achieve method objectives, resolutions between the 10 peaks were chosen as critical method attributes (CMAs) to be optimized through QbD approach. Based on a quality risk assessment, pH, temperature, and gradient slope were then selected as critical method parameters (CMPs) and a three level full factorial design was used to model the CMAs as function of the CMPs. Response surface methodology associated to Monte Carlo simulations allowed to determine the method operable domain region (MODR), i.e., the multidimensional combination of CMPs where CMAs simultaneously satisfied specifications (Rs ≥ 1.5) with a probability at least equal to 95 %. Inside the MODR, the working point was chosen based on green criteria, involving a mobile phase composed of ethanol and 10 mM acetic acid only as pH modifier. The method was successfully validated for all impurities using accuracy profile methodology, which was fully compliant with the ICH Q2(R1) requirements. Finally, the method was applied to the analysis of amodiaquine and artesunate impurities in raw materials and formulations.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
A green analytical chemistry strategy is described to develop a reversed‐phase high‐performance liquid chromatography method for amodiaquine and artesunate analysis using ethanol‐based mobile phases. ...This method development was particularly challenging due to the basicity of amodiaquine and low UV absorption of artesunate, leading to peak asymmetry and detection issues, respectively. UV detection concern was even more challenging due to the baseline drift observed with ethanol in gradient mode. Several green pH modifiers were selected for their ecofriendly character and their impact on peak shape and detection was investigated. The screening of various stationary phases (19 columns) appeared as a relevant and necessary approach to reach satisfactory peak shape of basic compounds. To support the results of this study, some additional compounds related to artesunate and amodiaquine structures were included. Methods were optimized and validated using total error approach with a mobile phase composed of ethanol and 10 mM formic acid using three different stationary phases from different manufacturers, providing flexibility of the quality control approach. Method greenness was assessed using the National Environmental Methods Index, the Green Analytical Procedure Index, and the Analytical Eco‐Scale. Finally, artesunate and amodiaquine were successfully analyzed in fixed dose combination tablets.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Two green analytical approaches have been developed for the analysis of antimalarial fixed dose tablets of artemether and lumefantrine for quality control. The first approach consisted of ...investigating the qualitative performance of a low-cost handheld near-infrared spectrometer in combination with the principal component analysis as an exploratory tool to identify trends, similarities, and differences between pharmaceutical samples, before applying the data driven soft independent modeling of class analogy (DD-SIMCA) as a one-class classifier for proper drug falsification detection with 100% of both sensitivity and specificity in the studied cases. Despite its limited spectral range and low resolution, the handheld device allowed detecting falsified drugs with no active pharmaceutical ingredient and identifying specifically a pharmaceutical tablet brand name. The second approach was the quantitative analysis based on the green and fast RP-HPLC technique using ethanol as a green organic solvent and acetic acid as a green pH modifier. The optimal separation was achieved in 7 min using a mobile phase composed of ethanol 96% and 10 mM of acetic acid pH 3.35 (63:37,
/
). The developed method was validated according to the total error approach based on an accuracy profile, was applied to the analysis of tablets, and allowed confirming falsified drugs detected by spectroscopy.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
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•Supercritical carbon dioxide for the production and sterilization of liposomes in a one-step process.•Optimization of a process with a quality by design strategy.•Final liposomes ...with required sterility assurance level and physicochemical characteristics for drug delivery.•Adapted process to several liposome formulations with hydrophobic active pharmaceutical ingredients.
Liposomes are very interesting drug delivery systems for pharmaceutical and therapeutic purposes. However, liposome sterilization as well as their industrial manufacturing remain challenging. Supercritical carbon dioxide is an innovative technology that can potentially overcome these limitations. The aim of this study was to optimize a one-step process for producing and sterilizing liposomes using supercritical CO2. For this purpose, a design of experiment was conducted. The analysis of the experimental design showed that the temperature is the most influential parameter to achieve the sterility assurance level (SAL) required for liposomes (≤10−6). Optimal conditions (80 °C, 240 bar, 30 min) were identified to obtain the fixed critical quality attributes of liposomes. The conditions for preparing and sterilizing empty liposomes of various compositions, as well as liposomes containing the poorly water-soluble drug budesonide, were validated. The results indicate that the liposomes have appropriate physicochemical characteristics for drug delivery, with a size of 200 nm or less and a PdI of 0.35 or less. Additionally, all liposome formulations demonstrated the required SAL and sterility at concentrations of 5 and 45 mM, with high encapsulation efficiency.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Shea butter is an important lipid material for food, cosmetic, and pharmaceutical industries. Most of the shea butter consumed in the world comes from Africa. The extraction protocol is not ...standardized among all regions of production. It can be done using either traditional or improved (semi-mechanical) processes. The quality of shea butter and its composition depend on multiple factors such as the edaphic parameters, morphology and harvesting method of the fruits, and treatment applied to fruits, nuts, and kernels, respectively. In this paper, all traditional and improved extraction processes reported, including the enormous possible variants, were reviewed and summarized. Several optimal conditions have been defined for both the traditional and the modern processes. Nevertheless, we are far from process harmonization, and therefore from the best conditions of shea butter processing. The screw press extraction was the most widely used among the modern processes due to its yield of butter extraction of about 82%. Microwave-assisted extraction gave the highest butter yield, 88%, and traditional shea butter extraction was about 20–35%.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
A selective and sensitive electroanalytical method was developed for arsenic determination based on a nanogold (AuNP) modified solid carbon paste working electrode (SCPE) modified in two steps (i) ...physisorption and (ii) additional electrodeposition of nanogold particles in the presence of iodide. Copper(II) interference was solved by covering the gold layer by a self assembled mono layer (SAM) of glutathione. Using DPASV a linear response of the signal was obtained as a function of As(III) in the concentration range 0.05–20 µM (4–1498 ppb) with a limit of detection of 0.01 µM (0.9 ppb). Sample stirring and degassing were not needed. Application to the determination of arsenic(III) and (V) in underground water samples from Burkina Faso was successfully achieved.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Natural laterite fixed-bed columns intercalated with two types of layers (inert materials, such as fine sand and gravel, and adsorbent materials, such as activated carbon prepared from Balanites ...aegyptiaca (BA-AC)) were used for As(III) removal from an aqueous solution. Investigations were carried out to solve the problem of column clogging, which appears during the percolation of water through a natural laterite fixed-bed column. Experimental tests were conducted to evaluate the hydraulic conductivities of several fixed-bed column configurations and the effects of various parameters, such as the grain size, bed height, and initial As(III) concentration. The permeability data show that, among the different types of fixed-bed columns investigated, the one filled with repeating layers of laterite and activated carbon is more suitable for As(III) adsorption, in terms of performance and cost, than the others (i.e., non-intercalated laterite; non-intercalated activated carbon, repeating layers of laterite and fine sand; and repeating layers of laterite and gravel). A study was carried out to determine the most efficient column using breakthrough curves. The breakthrough increased from 15 to 85 h with an increase in the bed height from 20 to 40 cm and decreased from 247 to 32 h with an increase in the initial As(III) concentration from 0.5 to 2 mg/L. The Bohart–Adams model results show that increasing the bed height induced a decrease in the kAB and N0 values. The critical bed depths determined using the bed depth service time (BDST) model for As(III) removal were 15.23 and 7.98 cm for 1 and 20% breakthroughs, respectively. The results show that the new low-cost adsorptive porous system based on laterite layers with alternating BA-AC layers can be used for the treatment of arsenic-contaminated water.
The aim of this study was to establish a comparative analysis of the physicochemical and the thermal behavior by
p-NMR
for solid fat content (SFC), and differential scanning calorimetry (DSC) of shea ...butter (SB) from Burkina Faso, related to different traditional extraction processes. Thirty-seven samples obtained from different localities were collected from local producers and analyzed for chemical indexes, unsaponifiable matter content (UMC), color, yellow index, fatty acids (FA) profile, and thermal behavior. Results showed that stearic acid (34%−47.2%) and oleic acid (40.8%−51%) were the most abundant FA. Chemical quality variations among those samples were observed: UMC (3.0%±1.0%–12.0%±0.1%), peroxide value (4.6 ± 0.1 to 44.5 ± 0.2 meqO
2
/kg), iodine value by GC (50.5 to 64.2), free fatty acids (1.1%± 0.1%–9.7%±0.1%). Statistically significant relationships were observed between thermal properties and chemical parameters. The results were subjected to clustering and principal component analysis (PCA). Results showed that a great diversity exists among crude shea butter samples from Burkina Faso which is due to both regional variation and difference in extraction processes. A standardization of the process could help to improve the quality.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
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