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Green versatile micellar electrokinetic chromatographic method for determination of six antimicrobial and anti-inflammatory drugs in combined dosage forms

Elmansi Heba, El-Awady Mohamed I., Barghash Sona, El-Razeq Sawsan Abd, Belal Fathalla

Acta Chromatographica

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2023

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Vol. 35, no. 3

233--246

EN

A fast reliable micellar electrokinetic methodology was investigated for the concurrent quantitation of six antimicrobial and anti-inflammatory drugs, namely, ciprofloxacin, dexamethasone, metronidazole, ornidazole, spiramycin and tinidazole. The method has the merits of rapidity, precision, and sensitivity. The separation was carried out in less than 7 min by applying a basic background electrolyte consisting of 25 mM disodium tetraborate buffer, pH 9 containing 50 mM SDS at 25 kV using photodiode array detector at 230 and 315 nm. The internal standard used during analysis was cromolyn sodium and validation was carried out following ICH guidelines. The proposed method showed linear response over the range from 0.5 to 10.0 μg mL⁻¹ reaching limits of detection and limits of quantitation in the ranges of 0.09–0.2 μg mL⁻¹ and 0.27–0.6 respectively. The method's greenness was estimated using the GAPI tool where excellent greenness was concluded. Co-formulated or single-ingredient commercial preparations were investigated and the results were statistically evaluated.

2

HPLC method for simultaneous determination of metronidazole and preservatives in vaginal gel formulation

Maslarska V., Tsvetkova B., Peikova L., Bozhanov S.

Acta Chromatographica

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2018

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Vol. 30, no. 2

127--130

EN

A high-performance liquid chromatography (HPLC) method with ultraviolet (UV) detection for simultaneous determination of metronidazole, methylparaben, and propylparaben in vaginal gel formulation was described. The chromatography was carried out on a C18 (250 mm × 4.6 mm, 5 μm) column with acetonitrile and 0.3% phosphoric acid solution (20:80 v/v) modified by 0.1% triethylamine as mobile phase, at a flow rate of 1.0 mL min-1, with detection at 260 nm. Under these chromatographic conditions, the obtained retention times were approximately 3.43 min for metronidazole, 5.17 min for propylparaben, and 15.12 min for methylparaben. Analytical parameters specificity, linearity, accuracy, and precision were determined by validation procedure and found to be satisfactory. Overall, the proposed method was found to be simple, precise, and accurate for quality control of metronidazole in the presence of preservatives in gel formulation.

3

Alginate based hydrogel for tissue regeneration: optimization, antibacterial activity and mechanical properties

Kaczmarek-Pawelska A., Winiarczyk K., Mazurek J.

Journal of Achievements in Materials and Manufacturing Engineering

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2017

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Vol. 81, nr 1

35--40

EN

Purpose: In this work our aim was to reveal the relationship between sodium alginate concentration and crosslinking level, also the ratio of release of the antibacterial additives: silver nanoparticles and metronidazole. Moreover, we examine obtained hydrogel as a potential dressing material for regenerative medicine. Design/methodology/approach: In the research specimens of hydrogels were tested to define their mechanical and physicochemical properties like antibacterial activity against gramnegative Escherichia coli and gram-positive Staphylococcus aureus, viscosity and conductivity. Findings: The concentration of alginate and presence of antibacterial additives influence on the crosslinking level. Mechanical properties of hydrogels are similar to human skin. Only hydrogels with addition of metronidazole and AgNP inhibits bacteria growth after 18 h. In case of gram-negative Escherichia coli both of the aseptic additives inhibits bacteria growth, but sodium alginate hydrogel with silver nanoparticles gives better results in tests with grampositive Staphylococcus aureus . Research limitations/implications: The presence of metronidazole in hydrogel, especially its incorporation and binding with mannuronic and guluronic acid residues must be clarified in more advanced research. Practical implications: Obtained results shows that sodium alginate hydrogels with 0.1mg/ml of alginate, due to its properties are proper as a dressing material. Based on the results, and more advanced tests with metronidazole, we can consider dressing design. Originality/value: Unique value of this work is that we completed the gap in knowledge about the relation of crosslinking level and mechanical properties with are crucial to proper tissue healing and addition of popular aseptic agents.

4

Development of quantitative HPTLC–densitometry methods following a model approach for transfer of TLC screening methods for pharmaceutical products of cefixime, cefuroxime axetil, cephalexin⋅H2O, ciprofloxacin HCl, levofloxacin, and metronidazole

Zhang D., Armour E., Sherma J.

Acta Chromatographica

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2017

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Vol. 29, no. 4

484--486

EN

Transfer of six thin-layer chromatography (TLC) Global Pharma Health Fund Minilab kit protocols for detecting fake or markedly substandard drugs in pharmaceutical products in the field to quantitative high-performance TLC (HPTLC)–densitometry methods was carried out using a model process published earlier. The developed and validated methods for tablets or capsules containing cefixime, cefuroxime axetil, cephalexin•H2O, ciprofloxacin HCl, levofloxacin, and metronidazole involved use of EMD Millipore Premium Purity silica gel 60 F254 plates, automated sample and standard solution application with a CAMAG Linomat 4, and automated densitometry with a CAMAG Scanner 3 for detection, identification, and quantification.

5

Use of Escherichia Coli K-12 Strain With Gfp Reporter Gene for Screening of Cefuroxime and Metronidazole Residues in Surface Water

Matejczyk M., Rosochacki S. J., Jabłonowski K.

Journal of Ecological Engineering

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2015

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Vol. 16, nr 3

77--82

EN

Antibiotic residues are constantly detected in environmental waters at relatively low concentrations. They can modulate the biological stability of ecosystems after entering the environment, therefore robust and reliable methods for determining their residues in environmental samples are required. In this work, Escherichia coli K-12 GFP-based bacterial biosensors strain was used to detect cyto- and genotoxic activity of cefuroxime and metronidazole at concentration of 500, 1000, 2000, 3000 and 5000 μg/ml. Experimental data indicated that metronidazole, at higher concentrations of 3000 and 5000 μg/ml showed stronger cyto- and genotoxix activity than cefuroxime to bacteria cells. Incubation of bacteria cells with surface water with both drugs modulated gfp gene expression. E. coli K-12 strain with genetic fusion of recA promoter and gfp reporter gene was a good model organism for screening cyto- and genotoxic effect of cefuroxime and metronidazole in applied in this experiment concentrations of these drugs.

6

Development of gradient HPLC-DAD method for assay of ternary mixture containing amebicide and analgesic drugs

Youssef R. M.

Acta Chromatographica

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2014

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Vol. 26, no. 1

67--80

EN

Validated gradient high-performance liquid chromatography-diode array detection (HPLC-DAD) method has been developed for simultaneous determination of diloxanide furoate (DIL), mebeverine hydrochloride (MBV), and metronidazole (MET) in their pharmaceutical preparation. This method was based on a reversed-phase HPLC separation of the cited drugs on a C-18 column (150 mm × 4.6 mm, 5 μm) with a gradient elution system of 0.05 M phosphate buffer with 1% (v/v) of triethylamine adjusted to pH 3.0-methanol as the mobile phase at the flow rate of 1.0 mL min -1. The separation was carried out at ambient temperature. Quantitation was achieved with DAD detection at 260 nm for DIL and MEB, and at 320 for MET based on peak area with linear calibration curves at concentration ranges 4–30, 1–20, and 1–30 μg mL -1 for DIL, MEB, and MET, respectively. The proposed chromatographic method was successfully applied to the determination of the investigated drugs in pharmaceutical preparation. It was validated in compliance with International Conference on Harmonization (ICH) guidelines, in terms of linearity, accuracy, precision, robustness, limits of detection, and quantitation and other aspects of analytical validation.

7

Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence studies

Emami J, Rezazadeh M

Acta Chromatographica

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2013

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Vol. 25, no. 1

111--125

EN

A simple, rapid, and sensitive reversed-phase HPLC method was developed and validated for determination of metronidazole and tinidazole in human plasma samples under identical chromatographic conditions. This method involves liquid-liquid extraction using chloroform: isopropylalcohol (95:5). Chromatographic separation was performed using a μ-bondapack C18 (250 mm × 4.6 mm) column. The mobile phase consisted of potassium dihydrogen phosphate solution (0.005 M)/acetonitrile (80/20 v/v). The final pH of the mobile phase was adjusted to 4 ± 0.1 with orthophosphoric acid. The calibration curves were linear over the concentration range 0.1–15 μg/mL for metronidazole and tinidazole with the detection limit of 30 ng/mL. Within- and between-day precision and accuracy did not exceed 9.83% and 10.48%, respectively. Metronidazole and tinidazole were found to be stable in plasma samples with no evidence of degradation during 3 freeze-thaw cycles and 3 months storage in −70 °C. The current validated bio-analytical method was finally applied in bioequivalence studies of two different metronidazole and tinidazole products according to a standard two-way cross-over design with a two-week washout period. No statistically significant difference was observed between the logarithmically transformed AUC0-∞ and Cmax values. Therefore, generic products were considered bioequivalent with those of standards which could be used interchangeably.

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Biodegradowalny polimerowy system uwalniania radiouczulacza - badania in vitro

Buszman A., Kasperczyk J., Jarząbek B., Stokłosa K., Smola A.

Engineering of Biomaterials

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2010

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Vol. 13, no. 99-101

67--71

PL

W pracy przedstawiono wyniki badań uwalniania radiouczulacza metronidazolu z jednowarstwowych oraz trójwarstwowych matryc kopolimeru glkolidu z laktydem do sztucznego płynu mózgowo rdzeniowego ACFs. Przeprowadzono analizę mikrostruktury łańcuchów polimerowych w oparciu o spektroskopię magnetycznego rezonansu jądrowego. Badanie uwalniania leku prowadzono w systemie dynamicznym z regularną wymianą buforu we fiolkach poddanych wytrząsaniu. Ekstrakty analizowano metodą spektrometrii UV-VIS. Równolegle prowadzono badania degradacji matryc z lekiem pod kątem oceny zmian w mikrostrukturze łańcucha polimerowego. Badania wykazały znacznie szybszą degradację matryc wykonanych z kopolimeru glikolidu z D,L-laktydem w porównaniu z matrycami z kopolimeru glikolidu z L-laktydem. Ponadto wykazano że opłaszczenie matrycy zawierającej lek polimerem bez leku (matryce trójwarstwowe) zapobiega nagłemu wyrzutowi leku z powierzchni w pierwszych dniach uwalniania.

EN

In this paper the results of radiosensitizer metronidazole release investigation from mono- and triple-layered copolymeric matrices in artificial cerebro- spinal fluid solution (ACFs) are presented. The analysis of polymeric chain microstructure by the NMR has been conducted. Drug release study was performed in the dynamic system with regular buffer exchange in constantly stirred glass ampoules. The extracts were analyzed by the UV-VIS spectrometry. Drug carrying matrices degradation research were conducted to evaluate possible changes in polymeric chain microstructure. The results showed that matrices containing poly(glycolide-co-D,L-lactide) demonstrate higher degradation rate than matrices containing poly(glycolide-co-L-lactide). It has been proved that drug carriers coated with drug-free polymer (triplelayered matrices) prevents from burst effect.