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See detailCritical review of surface-enhanced Raman spectroscopy applications in the pharmaceutical field
Cailletaud, Johan ULiege; De Bleye, Charlotte ULiege; Dumont, Elodie ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (in press)

Surface-enhanced Raman spectroscopy (SERS) is a sensitive analytical tool used in the pharmaceutical field in recent years. SERS keeps all the advantages of classical Raman spectroscopy while being is ... [more ▼]

Surface-enhanced Raman spectroscopy (SERS) is a sensitive analytical tool used in the pharmaceutical field in recent years. SERS keeps all the advantages of classical Raman spectroscopy while being is more sensitive allowing its use for the detection and the quantification of low-dose substances contained in pharmaceutical samples. However, the analytical performance of SERS is limited due to the difficulty to implement a quantitative methodology correctly validated. Nevertheless, some studies reported the development of SERS quantitative methods especially in pharmaceutical approaches. In this context, this review presents the main concepts of the SERS technique. The different steps that need to be applied to develop a SERS quantitative method are also deeply described. The last part of the present manuscript gives a critical overview of the different SERS pharmaceutical applications that were developed for a non-exhaustive list of pharmaceutical compounds with the aim to highlights the validation criteria for each application. [less ▲]

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See detailWhole blood microsampling for the quantitation of estetrol without derivatization by liquid chromatography-tandem mass spectrometry
Nys, Gwenaël ULiege; Gallez, Anne ULiege; Kok, Miranda ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2017), 140

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See detailApplication of design space optimization strategy to the developmentof LC methods for simultaneous analysis of 18 antiretroviral medicinesand 4 major excipients used in various pharmaceutical formulations
Habyalimana, Védaste ULiege; Mbinze Kindenge, Jérémie ULiege; Yemoa, Loconon ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2017), 139

tAs one of the world’s most significant public health challenges in low- and middle-income countries,HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from coun ... [more ▼]

tAs one of the world’s most significant public health challenges in low- and middle-income countries,HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from coun-terfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviralmedicines (ARV) and 4 major excipients. Design of experiments and design space methodology wereinitially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations andfocusing on rapidity and affordability thus using short column and low cost organic solvent (methanol)in gradient mode with 10 mM buffer solutions of ammonium hydrogen carbonate. Two other specificmethods dedicated to ARV in liquid and in solid dosage formulations were also predicted and opti-mized. We checked the ability of one method for the analysis of a fixed-dose combination composedby emtricitabine/tenofovir/efavirenz in tablet formulations. Satisfying validation results were obtainedby applying the total error approach taking into account the accuracy profile as decision tool. Then, thevalidated method was applied to test two samples coded A and B, and claimed to contain the tested ARV.Assay results were satisfying only for sample B. [less ▲]

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See detailQuantitative determination of salbutamol sulfate impurities using achiral supercritical fluid chromatography
Dispas, Amandine ULiege; Desfontaine, Vincent; Andri, Bertyl ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2017), 134

In the last years, supercritical fluid chromatography has largely been acknowledged as a singular and performing technique in the field of separation sciences. Recent studies highlighted the interest of ... [more ▼]

In the last years, supercritical fluid chromatography has largely been acknowledged as a singular and performing technique in the field of separation sciences. Recent studies highlighted the interest of SFC for the quality control of pharmaceuticals, especially in the case of the determination of the active pharmaceutical ingredient (API).Nevertheless, quality control requires also the determination of impurities. The objectives of the present work were to i) demonstrate the interest of SFC as a reference technique for the determination of impurities in salbutamol sulfate API and ii) to propose an alternative to a reference HPLC method from the European Pharmacopeia (EP) involving ionpairing reagent. Firstly, a screening was carried out to select the most adequate and selective stationary phase. Secondly, in the context of robust optimization strategy, the method was developed using design space methodology. The separation of salbutamol sulfate and related impurities was achieved in 7 minutes, which is seven times faster than the LC-UV method proposed by European Pharmacopeia (total run time of 50 minutes). Finally, full validation using accuracy profile approach was successfully achieved for the determination of impurities B, D, F and G in salbutamol sulfate raw material. The validated dosing range covered 50 to 150 % of the targeted concentration (corresponding to 0.3 % concentration level), LODs close to 0.5 μg/mL were estimated. The SFC method proposed in this study could be presented as a suitable fast alternative to EP LC method for the quantitative determination of salbutamol impurities. [less ▲]

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See detailVolumetric absorptive microsampling: Current advances and applications.
Kok, Miranda ULiege; Fillet, Marianne ULiege

in Journal of Pharmaceutical & Biomedical Analysis (2017)

Recently, volumetric absorptive microsampling (VAMS) has been introduced for the sampling of biological fluids, and more particularly whole blood, on a porous hydrophilic tip. VAMS enables the collection ... [more ▼]

Recently, volumetric absorptive microsampling (VAMS) has been introduced for the sampling of biological fluids, and more particularly whole blood, on a porous hydrophilic tip. VAMS enables the collection of small, accurate and precise blood volumes (10 or 20muL) regardless of the hematocrit. After drying, the samples can be stored or directly analyzed. The stability of various compounds in dried samples supported on VAMS tips varies from one day to a few months at room temperature, and increases at lower temperatures. The complete tip is used during a simple and straightforward sample preparation. Compounds can be extracted with a variety of solvents, and thereafter directly analyzed. A design of experiments is recommended to determine the optimal extraction conditions for a reproducible recovery. The recovery of compounds might be influenced by the hematocrit. In the last two years, various pharmacokinetic and therapeutic drug monitoring studies have been conducted with VAMS. This review covers the general aspects related with the use of VAMS and its applicability is demonstrated through examples. [less ▲]

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See detailSimultaneous analysis of nucleobases, nucleosides and ginsenosides in ginseng extracts using supercritical fluid chromatography coupled with single quadrupole mass spectrometry.
Huang, Yang; Zhang, Tingting; Zhao, Yumei et al

in Journal of Pharmaceutical & Biomedical Analysis (2017)

Nucleobases, nucleosides and ginsenosides, which have a significant impact on the physiological activity of organisms, are reported to be the active components of ginseng, while they are less present in ... [more ▼]

Nucleobases, nucleosides and ginsenosides, which have a significant impact on the physiological activity of organisms, are reported to be the active components of ginseng, while they are less present in ginseng extracts. Few analytical methods have been developed so far to simultaneously analyze these three classes of compounds with different polarities present in ginseng extracts. In the present study, a simple and efficient analytical method was successfully developed for the simultaneous separation of 17 nucleobases, nucleosides and ginsenosides in ginseng extracts using supercritical fluid chromatography coupled with single quadrupole mass spectrometry (SFC-MS). The effect of various experimental factors on the separation performance, such as the column type, temperature and backpressure, the type of modifier and additive, and the concentration of make-up solvent were systematically investigated. Under the selected conditions, the developed method was successfully applied to the quality evaluation of 14 batches of ginseng extracts from different origins. The results obtained for the different batches indicate that this method could be employed for the quality assessment of ginseng extracts. [less ▲]

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See detailDevelopment and validation of a fast SFC method for the analysis of flavonoids in plant extracts.
Huang, Yang; Feng, Ying; Tang, Guangyun et al

in Journal of Pharmaceutical & Biomedical Analysis (2017), 140

Flavonoids from plants always show a wide range of biological activities. In the present study, a rapid and highly efficient supercritical fluid chromatography (SFC) method was developed for the ... [more ▼]

Flavonoids from plants always show a wide range of biological activities. In the present study, a rapid and highly efficient supercritical fluid chromatography (SFC) method was developed for the separation of 12 flavonoids. After careful optimization, the 12 flavonoids were baseline separated on a ZORBAX RX-SIL column using gradient elution. A 0.1% phosphoric acid solution in methanol was found to be the most suitable polar mobile phase component for the separation of flavonoids. From the viewpoint of retention and resolution, a backpressure of 200bar and a temperature of 40 degrees C were shown to give the best results. Compared with a previously developed reverse phase liquid chromatography method, the SFC method could provide flavonoid separations that were about three times faster, while maintaining good peak shape and comparable peak efficiency. This SFC method was validated and applied to the analysis of five flavonoids (kaempferol, luteolin, quercetin, luteoloside, buddleoside) present in Chrysanthemum morifolium Ramat. from different cultivars (Chuju, Gongju, Hangju, Boju). The results indicated a good repeatability and sensitivity for the quantification of the five analytes with RSDs for overall precision lower than 3%. The limits of detection ranged from 0.73 to 2.34mug/mL, while the limits of quantification were between 2.19 and 5.86mug/mL. The method showed that SFC could be employed as a useful tool for the quality assessment of Traditional Chinese medicines (TCMs) containing flavonoids as active components. [less ▲]

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See detailVolumetric absorptive microsampling: Current advances and applications.
Kok, Miranda ULiege; Fillet, Marianne ULiege

in Journal of Pharmaceutical & Biomedical Analysis (2017)

Recently, volumetric absorptive microsampling (VAMS) has been introduced for the sampling of biological fluids, and more particularly whole blood, on a porous hydrophilic tip. VAMS enables the collection ... [more ▼]

Recently, volumetric absorptive microsampling (VAMS) has been introduced for the sampling of biological fluids, and more particularly whole blood, on a porous hydrophilic tip. VAMS enables the collection of small, accurate and precise blood volumes (10 or 20muL) regardless of the hematocrit. After drying, the samples can be stored or directly analyzed. The stability of various compounds in dried samples supported on VAMS tips varies from one day to a few months at room temperature, and increases at lower temperatures. The complete tip is used during a simple and straightforward sample preparation. Compounds can be extracted with a variety of solvents, and thereafter directly analyzed. A design of experiments is recommended to determine the optimal extraction conditions for a reproducible recovery. The recovery of compounds might be influenced by the hematocrit. In the last two years, various pharmacokinetic and therapeutic drug monitoring studies have been conducted with VAMS. This review covers the general aspects related with the use of VAMS and its applicability is demonstrated through examples. [less ▲]

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See detailCapillary electrophoresis in the context of drug discovery.
Farcas, Elena ULiege; Pochet, Lionel; Crommen, Jacques ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2017)

Capillary Electrophoresis is a very efficient and resolutive separation technique used for many years in the analytical field. Despite all its assets, CE remains poorly used in drug discovery. This can be ... [more ▼]

Capillary Electrophoresis is a very efficient and resolutive separation technique used for many years in the analytical field. Despite all its assets, CE remains poorly used in drug discovery. This can be explained by the relatively low number of experienced CE practitioners, the maturity of HPLC in the pharmaceutical industry and some intrinsic limitations of the technique. The objective of this review is to focus our attention on recent developments of this technique in three different drug discovery areas: bioassays, drug-plasma interactions and drug metabolism studies. These developments were based on two important abilities of CE: the capacity to measure non-covalent interactions in solution and the ability to use a portion of the capillary as a reactor while the rest of the capillary is used for the separation of the product of the reaction. [less ▲]

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See detailMoisture content determination in an antibody-drug conjugate freeze-dried medicine by near-infrared spectroscopy: a case study for release testing
Clavaud, Matthieu ULiege; Roggo, Yves; Dégardin, Klara et al

in Journal of Pharmaceutical & Biomedical Analysis (2016), 131

The use of Near-infrared spectroscopy (NIRS) as a fast and non-destructive technique was employed for moisture content (MC) determination in Antibody-drug conjugates (ADCs) in replacement to Karl Fischer ... [more ▼]

The use of Near-infrared spectroscopy (NIRS) as a fast and non-destructive technique was employed for moisture content (MC) determination in Antibody-drug conjugates (ADCs) in replacement to Karl Fischer (KF) method. The lab analysis of ADCs, high potent medicines, should be performed in conditions ensuring the operator’s safety and using secured analytical tools like NIRS. A NIRS method was first developed and validated in compliance with current guidelines. The novelty of this work first lies in the large number of samples prepared for a wide moisture calibration range of 0.51% to 4.01%. Then, the classical Partial Least Square (PLS) regression was used as chemometric tool for the computation of the model. Excellent predictive calibration results were shown. A coefficient of correlation (r) value of 0.99 was obtained. An intercept value of 0.02 and a slope of 0.99 were observed, while the root mean square error of calibration (RMSEC) and the root mean square error of prediction (RMSEP) were respectively 0.10% and 0.12%. In addition, instrumentation, model performances and robustness of the method were evaluated, demonstrating the validation results. Calibration transfer issue and impact of the number of samples were also evaluated. Consequently, a validation strategy was introduced as a basis for submission to the health authorities’ for release and stability activities in a cGMP environment in replacement of the KF method. [less ▲]

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See detailFingerprinting and validation of a LC-DAD method for the analysis of biflavanones in Garcinia kola-based antimalarial improved traditional medicines
Tshisekedi Tshibangu, Pascal ULiege; Mutwale Kapepula, Paulin ULiege; Kabongo Kapinga, Marie Josée et al

in Journal of Pharmaceutical & Biomedical Analysis (2016), 128(2016), 382-390

African populations use traditional medicines in their initial attempt to treat a range of diseases. Nevertheless, accurate knowledge of the composition of these drugs remains a challenge in terms of ... [more ▼]

African populations use traditional medicines in their initial attempt to treat a range of diseases. Nevertheless, accurate knowledge of the composition of these drugs remains a challenge in terms of ensuring the health of population and in order to advance towards improved traditional medicines (ITMs). In this paper chromatographic methods were developed for qualitative and quantitative analyses of a per os antimalarial ITM containing Garcinia kola. The identified analytical markers were used to establish TLC and HPLC fingerprints. G. kola seeds were analysed by HPLC to confirm the identity of the extract used by the Congolese manufacturer in the ITM. The main compounds (GB1, GB2, GB-1a and Kolaflavanone) were isolated by preparative TLC and identified by UPLC–MS and NMR. For the quantification of the major compound GB1, a simple and rapid experimental design was applied to develop an LC method, and then its validation was demonstrated using the total error strategy with the accuracy profile as a decision tool. The accurate results were observed within 0.14–0.45 mg/mL range of GB1 expressed as naringenin. The extracts used in several batches of the analysed oral solutions contained GB1 (expressed as naringenin) within 2.04–2.43%. Both the fingerprints and the validated LC-DAD were found suitable for the quality control of G. kolabased raw material and finished products, respectively. [less ▲]

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See detailScreening study of SFC critical method parameters for the determination of pharmaceutical compounds
Dispas, Amandine ULiege; Lebrun, Pierre ULiege; Sacre, Pierre-Yves ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2016), 125

Nowadays, supercritical fluid chromatography is commonly presented as a promising alternative technique in the field of separation sciences. Nevertheless the selection of chromatographic conditions and ... [more ▼]

Nowadays, supercritical fluid chromatography is commonly presented as a promising alternative technique in the field of separation sciences. Nevertheless the selection of chromatographic conditions and sample preparation of pharmaceutical compounds remain a challenge and peak distortion was previously highlighted. The main objective of the present work was to evaluate the impact of different critical method parameters (CMPs), i.e. stationary phase, mobile phase composition and injection solvent nature. The experiments were performed considering two groups of antimalarial molecules: one group with neutral/apolar compounds and the other one with salt form of polar compounds. In this context, another objective was to propose a suitable sample solvent for quantitative analysis. The interest of new generation stationary phase to obtain good peak shape and the interest to tune the mobile phase composition were demonstrated. During this study, design of experiments and desirability function approach enabled to highlight optimal chromatographic conditions in order to maximise peak capacity and to get acceptable value of symmetry factor. Regarding sample injection solvent composition, some counterintuitive results were observed: solvents closer to the mobile phase polarity (i.e heptane or 2-propanol/heptane mixture) did not provide best results in terms of peak symmetry. In addition, acetonitrile and short aliphatic alcohols offered an interesting alternative as injection solvent: toxicity of solvents used is clearly reduced and better quantitative performances could be expected while keeping high peak capacity and symmetric sharp peaks. Finally, the quantitative performances were evaluated by the method validation for the quantitative determination of quinine sulfate in a pharmaceutical formulation. These better understandings on critical method parameters led SFC to be an even more promising technique in the field of the analysis of pharmaceutical compounds. [less ▲]

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See detailDevelopment, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops.
Mbinze Kidenge, Jérémie; Sacre, Pierre-Yves ULiege; Yemoa, Achille et al

in Journal of Pharmaceutical & Biomedical Analysis (2015), 111

Poor quality antimalarial drugs are one of the public’s major health problems in Africa. The depth of this problem may be explained in part by the lack of effective enforcement and the lack of efficient ... [more ▼]

Poor quality antimalarial drugs are one of the public’s major health problems in Africa. The depth of this problem may be explained in part by the lack of effective enforcement and the lack of efficient local drug analysis laboratories. To tackle part of this issue, two spectroscopic methods with the ability to detect and to quantify quinine dihydrochloride in children’s oral drops formulations were developed and validated. Raman and Near Infrared (NIR) spectroscopy were selected for the drug analysis due to their low cost, non-destructive and rapid characteristics. Both of the methods developed were successfully validated using the total error approach in the range of 50-150% of the target concentration (20% W/V) within the 10% acceptance limits. Samples collected on the Congolese pharmaceutical market were analyzed by both techniques to detect potentially substandard drugs. After a comparison of the analytical performance of both methods, it has been decided to implement the method based on NIR spectroscopy to perform the routine analysis of quinine oral drop samples in the Quality Control Laboratory of Drugs at the University of Kinshasa (DRC). [less ▲]

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See detailReply to "a model lacking relevant literature comparison".
Wang, T.; Feng, Y.; Zhao, X. et al

in Journal of Pharmaceutical & Biomedical Analysis (2015), 104

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See detailSimultaneous determination of insulin and its analogues in pharmaceutical formulations by micellar electrokinetic chromatography
Lamalle, Caroline ULiege; Servais, Anne-Catherine ULiege; RADERMECKER, Régis ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2015)

A simple and efficient MEKC method was developed to simultaneously determine human insulin, its five analogues, the main degradation products and the excipients usually present in injection formulations ... [more ▼]

A simple and efficient MEKC method was developed to simultaneously determine human insulin, its five analogues, the main degradation products and the excipients usually present in injection formulations. A very fast method with a total analysis time of 3 min was then successfully validated for the analysis of human insulin and the quality control of different commercial formulations was carried out. [less ▲]

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See detailData processing of vibrational chemical imaging for pharmaceutical applications.
Sacre, Pierre-Yves ULiege; De Bleye, Charlotte ULiege; Chavez, Pierre-François ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2014), 101

Vibrational spectroscopy (MIR, NIR and Raman) based hyperspectral imaging is one of the most powerful tools analyze pharmaceutical preparation. Indeed, it combines the advantages of vibrational ... [more ▼]

Vibrational spectroscopy (MIR, NIR and Raman) based hyperspectral imaging is one of the most powerful tools analyze pharmaceutical preparation. Indeed, it combines the advantages of vibrational spectroscopy to imaging techniques and allows therefore the visualization of distribution of compounds, crystallization processes. However, these techniques provide a huge amount of data that must be processed to extract the relevant information. This review presents fundamental concepts of hyperspectral imaging, the basic theory of the most used chemometric tools used to pre-process, process and post-process the generated data. The last part of the present paper focuses on pharmaceutical applications of hyperspectral imaging and highlights the data processing approaches to enable the reader making the best choice among the different tools available. [less ▲]

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See detailTowards a real time release approach for manufacturing tablets using NIR spectroscopy
Pestieau, Aude ULiege; Krier, Fabrice ULiege; Thoorens, Grégory et al

in Journal of Pharmaceutical & Biomedical Analysis (2014), 98

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See detailDevelopment of a quantitative approach using surface-enhanced Raman chemical imaging: First step for the determination of an impurity in a pharmaceutical model
De Bleye, Charlotte ULiege; Sacre, Pierre-Yves ULiege; Dumont, Elodie ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2014), 90

This publication reports, for the first time, the development of a quantitative approach using surface-enhanced Raman chemical imaging (SER-CI). A pharmaceutical model presented as tablets based on ... [more ▼]

This publication reports, for the first time, the development of a quantitative approach using surface-enhanced Raman chemical imaging (SER-CI). A pharmaceutical model presented as tablets based on paracetamol, which is the most sold drug around the world, was used to develop this approach. 4-Aminophenol is the main impurity of paracetamol and is actively researched in pharmaceutical formulations because of its toxicity. As its concentration is generally very low (<0.1%, w/w), conventional Raman chemical imaging cannot be used. In this context, a SER-CI method was developed to quantify 4-aminophenol assessing a limit of quantification below its limit of specification of 1000 ppm. Citrate-reduced silver nanoparticles were used as SERS substrate and these nanoparticles were functionalized using 1-butanethiol. Different ways to cover the tablets surface by butanethiol-functionalized silver nanoparticles were tested and a homogeneity study of the silver nanoparticles covering was realized. This homogeneity study was performed in order to choose the best way to cover the surface of tablets by silver colloid. Afterwards, the optimization of the SER-CI approach was necessary and different spectral intensity normalizations were tested. Finally, a quantitative approach using SER-CI was developed enabling to quantify 4-aminophenol from 0.025% to 0.2% in paracetamol tablets. This quantitative approach was tested on two different series of tablets using different batches of silver nanoparticles. [less ▲]

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See detailDevelopment of a liquid chromatographic method for thesimultaneous quantification of curcumin, -arteether,tetrahydrocurcumin and dihydroartemisinin. Application to lipid-based formulations
Memvanga Bondo, Patrick; Mbinze Kindenge, Jérémie ULiege; Rozet, Eric ULiege et al

in Journal of Pharmaceutical & Biomedical Analysis (2014), 88

A liquid chromatographic method was developed for the simultaneous separation of curcumin, B-arteether, tetrahydrocurcumin and dihydroartemisinin based on the design of experiments and the design space ... [more ▼]

A liquid chromatographic method was developed for the simultaneous separation of curcumin, B-arteether, tetrahydrocurcumin and dihydroartemisinin based on the design of experiments and the design space methodology. The influence of the percentage of organic modifier, flow rate of the mobile phase and column temperature on the analytes separation was investigated. The optimal chromatographic separation was achieved on a C18 column (125 mm × 4 mm, 5 µm) using an isocratic elution with a mobile phase consisting of methanol:ammonium acetate (pH 4; 10 mM) (80/20, v/v) at a flow rate of 0.45 ml/min and a column temperature of 32.5◦C. This method was then validated for simultaneous quantification of curcumin and B -arteether contained in lipid-based formulations taking into account the B -expectation tolerance interval for the total error measurement. Finally, the suitability of the proposed liquid chromatographic method for routine analysis of curcumin and B -arteether loaded in lipid-based formulations has been proven. [less ▲]

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