Drugs Quality Control Laboratory

Rabat, Morocco

Drugs Quality Control Laboratory

Rabat, Morocco
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Al-Kamarany M.A.,Hodeidah University | Alwosaby A.S.,Hodeidah University | El Karbane M.,Drugs Quality Control Laboratory | Karouchi K.,Drugs Quality Control Laboratory
International Journal of Pharmacy and Pharmaceutical Sciences | Year: 2013

Objective: The study aims to validate a direct potentiometric method based on classical approach namely SFSTP guideline 1992 for quantification of sodium bicarbonate (SB) in grip water syrup marketed in Yemen. Methods: A potentiometric automatic titration method was used to SB in pharmaceutical products. The method was validated and applied to assay of SB in original and generic products. Results: The validated method was very precise to each analyte with percent relative standard deviation (RSD %) of intraday (0.96 %) and RSD % of interday (1.11%). The accuracy test of the validated method exhibited well mean recovery value of 99.46 % with confidant interval (98.68 % - 100.24 %). Furthermore, the coefficient correlation (R2) value was 0.9996. In addition, the results showed low dosage of active component which did not meet the acceptance criteria for SB in some generic products in the USP: 93%-107% of the stated amount per unit. Conclusion: The described analytical method is a simple, sensitive, specific, more accurate and useful for the assay of SB in grip water syrup and the findings showed poor quality of some generic grip water syrups available in Yemen and this problem may affect the efforts to control gastrointestinal discomfort. Efficient regulatory systems of drugs quality control should be implemented.


Radi M.,Drugs Quality Control Laboratory | Ramli Y.,Mohammed V University | El Karbane M.,Drugs Quality Control Laboratory | Elalami A.,Drugs Quality Control Laboratory | And 5 more authors.
Journal of Chemical and Pharmaceutical Research | Year: 2014

A simple, fast, economical, accurate, precise and reproducible RP – HPLC method was developed for the determination of Ibuprofen. The method was validated in terms of specificity, linearity, precision accuracy, and robustness. The proposed method’s results were found to be satisfactory and are suitable for determination of Ibuprofen for routine quality control of drugs in bulk drug and formulation. © 2014, Journal of Chemical and Pharmaceutical Research. All rights reserved.


Bouchafra H.,University Sidi Mohammed Ben Abdellah | Bouchafra H.,Drugs Quality Control Laboratory | Elkarbane M.,Drugs Quality Control Laboratory | Elkarbane M.,Mohammed V University | And 6 more authors.
Journal of Chemical and Pharmaceutical Research | Year: 2014

This research aims to propose a new vision to examine an analytical method during its life cycle, in order to show its performance and capability to guarantee good results for future analysis at a confidence level accepted. In this context, A method was proposed for separate and quantify simultaneously of five vitamins, that is ascorbic acid (vitamin C: VC), Thiamine hydrochloride (vitamin B1: VB1), Riboflavin (vitamin B2: VB2), Nicotinamide (vitamin B3: VB3) and Pyridoxine hydrochloride (vitamin B6: VB6) in tablet multivitamin. Chemometric tools, namely screening design factors (Plackett-Burman) and response surface methodology (Box-Behnken) were used to optimize the operating conditions of the liquid chromatography method chosen at the selection stage. The performances of the developed method were highlighted by applying of the approach based on the concept of the total error and accuracy profile. Results of accuracy profile showed that the 95%-expectation tolerance limits for all vitamins fell well within the acceptance limits at±10%. Therefore, chromatography method was capable of providing accurate results in the concentrations range studied of each vitamin. On the other hand, measurement uncertainty was calculated at each concentration level for each vitamin from validation data which these relative values did not exceed 5%. Finally, according to its life cycle, we can say that our method is apparent suitable for quality control the finished products contain water-soluble vitamins. © 2014, Journal of Chemical and Pharmaceutical Research. All rights reserved.


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.


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.

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