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Yahya M.S.,Mohammed V University | El Karbane M.,Drugs Quality Control Laboratory | Oturan N.,University Paris Est Creteil | El Kacemi K.,Mohammed V University | Oturan M.A.,University Paris Est Creteil
Environmental Technology (United Kingdom) | Year: 2016

The present study investigates the feasibility of using electro-Fenton (EF) process for the oxidative degradation of antibiotic levofloxacin (LEV). The EF experiments have been performed in an electrochemical cell using a carbon-felt cathode. The effect of applied current in the range 60-500mA and catalyst concentration in the range 0.05-0.5mM on the kinetics of oxidative degradation and mineralization efficiency have been investigated. Degradation of LEV by hydroxyl radicals was found to follow pseudo-first-order reaction kinetics. The absolute rate constant for oxidative degradation of LEV by hydroxyl radical has been determined by a competition kinetics method and found to be (2.48 ± 0.18) × 109M-1s-1. An optimum current value of 400mA and a catalyst (Fe2+) concentration of 0.1mM were observed to be optimal for an effective degradation of LEV under our operating conditions. Mineralization of aqueous solution of LEV was performed by the chemical oxygen demand analysis and an almost mineralization degree (>91%) was reached at the end of 6h of electrolysis. A number of intermediate products have been identified using high performance liquid chromatography and liquid chrmatography-mass spectrometry analyses. Based on these identified reaction intermediates, a plausible reaction pathway has been suggested for the mineralization process. The formation and evolution of and ions released to the medium during the process were also discussed. © 2015 Taylor & Francis.


Yahya M.S.,Mohammed V University | Oturan N.,University Paris Est Creteil | El Kacemi K.,Mohammed V University | El Karbane M.,Drugs Quality Control Laboratory | And 2 more authors.
Chemosphere | Year: 2014

Oxidative degradation of the antimicrobial agent ciprofloxacin hydrochloride (CIP) has been investigated using electro-Fenton (EF) treatment with a constant current in the range 60-500mA. The process generates highly oxidant species ·OH in situ via electrochemically monitored Fenton reaction. The EF experiments were performed using cells with a carbon felt cathode and Pt anode. Effect of applied current and catalyst concentration on the kinetics of oxidative degradation and mineralization efficiency have been investigated. Degradation of CIP followed pseudo-first order reaction kinetics. The rate constant of the oxidation of CIP by ·OH has been determined to be (1.01±0.14) × 1010 M-1 s-1 by using competitive kinetics method. An optimum current of 400mA and a catalyst concentration of Fe2+ at 0.1mM are found to be optimal for an effective degradation of CIP under our operating conditions. A remarkably high degree of mineralization (>94%) was obtained at 6h of treatment under these conditions. A number of stable intermediate products have been identified using HPLC and LC-MS/MS analyses. Based on the identified reaction intermediates, a plausible reaction pathway was proposed for the mineralization process. The high degree of mineralization obtained in this work highlights the potential application of EF process in the efficient removal of fluoroquinolone based drugs in aqueous medium. © 2014 Elsevier Ltd.


PubMed | Drugs Quality Control Laboratory, Mohammed V University and University Paris Est Creteil
Type: Journal Article | Journal: Environmental technology | Year: 2016

The present study investigates the feasibility of using electro-Fenton (EF) process for the oxidative degradation of antibiotic levofloxacin (LEV). The EF experiments have been performed in an electrochemical cell using a carbon-felt cathode. The effect of applied current in the range 60-500mA and catalyst concentration in the range 0.05-0.5mM on the kinetics of oxidative degradation and mineralization efficiency have been investigated. Degradation of LEV by hydroxyl radicals was found to follow pseudo-first-order reaction kinetics. The absolute rate constant for oxidative degradation of LEV by hydroxyl radical has been determined by a competition kinetics method and found to be (2.480.18)10(9)M(-1)s(-1). An optimum current value of 400mA and a catalyst (Fe(2+)) concentration of 0.1mM were observed to be optimal for an effective degradation of LEV under our operating conditions. Mineralization of aqueous solution of LEV was performed by the chemical oxygen demand analysis and an almost mineralization degree (>91%) was reached at the end of 6h of electrolysis. A number of intermediate products have been identified using high performance liquid chromatography and liquid chrmatography-mass spectrometry analyses. Based on these identified reaction intermediates, a plausible reaction pathway has been suggested for the mineralization process. The formation and evolution of [Formula: see text] and [Formula: see text] ions released to the medium during the process were also discussed.


PubMed | drugs quality control laboratory, Institute Superieur Des Professions Infirmieres Et Techniques Of Sante, Mazandaran University of Science and Technology and Hassan II University
Type: Journal Article | Journal: Annales pharmaceutiques francaises | Year: 2016

An innovative simple, fast, precise and accurate ultra-high performance liquid chromatography (UPLC) method was developed for the determination of diclofenac (Dic) along with its impurities including the new dimer impurity in various pharmaceutical dosage forms. An Acquity HSS T3 (C18, 1002.1mm, 1.8m) column in gradient mode was used with mobile phase comprising of phosphoric acid, which has a pH value of 2.3 and methanol. The flow rate and the injection volume were set at 0.35mlmin(-1) and 1l, respectively, and the UV detection was carried out at 254nm by using photodiode array detector. Dic was subjected to stress conditions from acid, base, hydrolytic, thermal, oxidative and photolytic degradation. The new developed method was successfully validated in accordance to the International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantitation, precision, linearity, accuracy and robustness. The degradation products were well resolved from main peak and its seven impurities, proving the specificity power of the method. The method showed good linearity with consistent recoveries for Dic content and its impurities. The relative percentage of standard deviation obtained for the repeatability and intermediate precision experiments was less than 3% and LOQ was less than 0.5gml(-1) for all compounds. The new proposed method was found to be accurate, precise, specific, linear and robust. In addition, the method was successfully applied for the assay determination of Dic and its impurities in the several pharmaceutical dosage forms.


Bourichi H.,Mohammed V University | Brik Y.,Drugs Quality Control Laboratory | Hubert P.,University of Liège | Cherrah Y.,Mohammed V University | Bouklouze A.,Mohammed V University
Journal of Pharmaceutical Analysis | Year: 2012

In this paper, we report the results of quality control based in physicochemical characterization and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid-state characterization of the three samples was realized with different physicochemical methods as: X-ray powder diffraction, Fourier-transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph III, sample B consisted in pure polymorph II, sample C consisted in a mixture of fluconazole Form III, form II and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the re-crystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specific impurities for each polymorphic form, and a possible relationship could be exist between impurities and crystalline form of fluconazole. © 2012 Xi'an Jiaotong University.


Elkarbane M.,Mohammed V University | Elkarbane M.,Drugs Quality Control Laboratory | Amood Al-Kamarany M.,Mohammed V University | Amood Al-Kamarany M.,Drugs Quality Control Laboratory | And 6 more authors.
Acta Chromatographica | Year: 2015

A gradient reversed phase high-performance liquid chromatography (RPHPLC) method with ultraviolet (UV) detection to analyze hydrochlorothiazide (HCT) and valsartan (VS) simultaneously in a tablet formulation during forced degradation studies was developed. This method was validated using a novel approach, namely, the accuracy profile or total errors approach. The robustness of the method was evaluated using a Plackett-Burman design for eight factors. The algorithm of Dong was applied to determine the significant factor effects. The validation results showed that the method is precise (RSD: 1.14% for HCT and 0.43% for VS) and accurate (mean recovery: 99.90% for HCT and 99.98% for VS). On the other hand, the results of the robustness study showed that the type of column was the important factor which affects a number of responses, namely, the asymmetry factor (AF), retention time (RT), and resolution (RS). However, the assay results were not affected; therefore, the method can be considered robust. Finally, the method was applied to study the stability of HCT and VS under forced conditions. Significant results were obtained with basic hydrolysis, oxidation, and thermal stress, while the accelerated and acidic conditions did not affect the stability of HCT or VS. © 2014 Akadémiai Kiadó, Budapest.


Sawadogo C.W.,Mohammed V University | Al-Kamarany M.A.,Mohammed V University | Al-Mekhlafi H.M.,University of Malaya | Al-Mekhlafi H.M.,Sana'a University | And 5 more authors.
Annals of Tropical Medicine and Parasitology | Year: 2011

Malaria is the biggest killer of African children, yet it is cheaply preventable and curable with insecticides spraying, impregnated bednets and effective drugs. This study aimed to evaluate the quality ofChloroquine (CQ) tablets available in selected African countries. Twenty-six samples of antimalarial CQ tablet of 100, 150 and 250 mg were collected from12 African countries and evaluated for their quality in the Drugs Quality Control Laboratory of Rabat, Morocco. The identification and dosage of active pharmaceutical ingredients in the tablets, dissolution rate, hardness and the friability of CQtabletswere performed according to the United States Pharmacopeia (USP) and European Pharmacopoeia (Eur.Ph.) recommended methods. The results showed that 7.7% of the sampled CQ tablets available in Burkina Faso were of low quality. Failure in dissolution profile was found in50%ofCQtablets sampled fromBenin,BurkinaFaso,ComorosUnion, Mali and Senegal.The findings showed poor quality ofCQtablets available in the Africanmarket. This problemmay affect the efforts to control malaria in Africa. Efficient regulatory systems of drugs quality control should be implemented. © W. S. Maney & Son Ltd 2011.


PubMed | drugs quality control laboratory, Institute Of Formation Aux Carrieres Of Sante Of Rabat and Mohammed V University
Type: Journal Article | Journal: Annales pharmaceutiques francaises | Year: 2014

A simple, rapid, and sensitive RP-HPLC method using photodiode array detection was developed and validated for the simultaneous determination of butylhydroxyanisol and simvastatin with its impurities in tablet forms. Chromatographic separation was achieved on a Phenomenex Hypersil (2504.6 mm, 5 m) column using the mobile phase acetonitrile-sodium acetate (12 mM) buffered to 4.2 with glacial acetic acid. The flow rate was 1.7 mL/min, and the UV detection were made at 238 nm for simvastatin and its impurities and at 290 nm for butylhydroxyanisol. The system suitability solution used for peak impurity identification was generated in-situ without use of any impurity reference standard. The method was validated according to ICH Q2(R1) guidelines, and the acceptance criteria for accuracy, precision, linearity, specificity, robustness, LOD, and LOQ, were met in all cases. Moreover, the reproducibility results obtained by 22 Official Medicines Control Laboratories (OMCL) of European Directorate were satisfactory. The compounds selected for impurity validation were based on those found during long term and accelerate stability studies carried out on several formulation tablets from Moroccan and other markets. The described method was robust and successfully applied in quality control laboratories for routine analysis to determine the butylhydroxyanisol and simvastatin with its impurities content in tablet dosage forms.


PubMed | Drugs Quality Control Laboratory and Mohammed V University
Type: Journal Article | Journal: Annales pharmaceutiques francaises | Year: 2016

The comparative pharmacokinetic behavior of albendazole (ABZ) and its new benzimidazol prodrug [1-tert-butyloxycarbonyl-5-propylthio-1-H-benzimidazol-2ylcarbamate of methyl] (ABZBoc), following their oral administration (10mg/kg) to healthy dogs was explored. Blood samples were obtained serially over a 24h period after treatment, then the plasma was analyzed by high-performance liquid chromatography (HPLC) to search the albendazole metabolites (ABZSO and ABZSO2). However, the albendazole parent drug was not detectable at any time after both treatments (ABZ and ABZBoc). By albendazole metabolites (ABZSO and ABZSO2) were the analytes recovered in the plasma after oral administration of ABZ and ABZBoc. Furthermore, some amounts of ABZBoc were also available in the plasma samples treated with this new produg. The plasma profile of each analyte followed a similar pattern after both treatments, the active metabolite (ABZSO) was the major analyte recovered in plasma (between 1 and 24h post-treatment). The pharmacokinetic parameters of both groups were calculated (Cmax, Tmax, t1/2, AUC0-), and analyzed using the Students t-test, P<0.05. Thus,the pharmacokinetic analysis indicated four statistically significant changes in the pharmacokinetic parameters defined above of the albendazole metabolites (ABZSO, ABZSO2) between the group treated with albendazole (group A) and that treated with ABZBoc prodrug (group B). Hence, the levels of the various pharmacokinetics parameters were low in the group treated with prodrug, as well they did not reach equivalent concentrations to that of albendazole. These differences between albendazole and its new prodrug may be explained by the fact that ABZBoc prodrug was not effectively reduced in the intestine of dogs.


El Karbane M.,Mohammed V University | El Karbane M.,Drugs quality control laboratory | Azougagh M.,Drugs quality control laboratory | Azougagh M.,Institute Of Formation Aux Carrieres Of Sante Of Rabat | And 5 more authors.
Annales Pharmaceutiques Francaises | Year: 2014

A simple, rapid, and sensitive RP-HPLC method using photodiode array detection was developed and validated for the simultaneous determination of butylhydroxyanisol and simvastatin with its impurities in tablet forms. Chromatographic separation was achieved on a Phenomenex Hypersil (250 × 4.6. mm, 5. μm) column using the mobile phase acetonitrile-sodium acetate (12. mM) buffered to 4.2 with glacial acetic acid. The flow rate was 1.7. mL/min, and the UV detection were made at 238. nm for simvastatin and its impurities and at 290. nm for butylhydroxyanisol. The system suitability solution used for peak impurity identification was generated in-situ without use of any impurity reference standard. The method was validated according to ICH Q2(R1) guidelines, and the acceptance criteria for accuracy, precision, linearity, specificity, robustness, LOD, and LOQ, were met in all cases. Moreover, the reproducibility results obtained by 22 Official Medicines Control Laboratories (OMCL) of European Directorate were satisfactory. The compounds selected for impurity validation were based on those found during long term and accelerate stability studies carried out on several formulation tablets from Moroccan and other markets. The described method was robust and successfully applied in quality control laboratories for routine analysis to determine the butylhydroxyanisol and simvastatin with its impurities content in tablet dosage forms. © 2014 Elsevier Masson SAS.

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