Development studies of a new metronidazole certified reference material

Nogueira, Raquel Fernandes Pupo; Rocha, Wérickson Fortunato de Carvalho; Silva, Thaís E.; Rego, Eliane C. P.; Moreira, Gabriela F.; Wollinger, Wagner; Rodrigues, Janaína Marques

doi:10.1590/s0103-50532012000300009

Cited by 4 publications

(3 citation statements)

References 15 publications

(21 reference statements)

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“…The MTC content was analyzed by HPLC after a short-term stability test to evaluate the behavior of the formulation during transport and by a long-term stability study to analyze the storage conditions. The studies showed the high stability of MTZ during both short and long-term tests of the analyzed preparation [36]. Wu et al analyzed the level of MTZ degradation under the influence of various factors, both in solid and liquid form.…”

Section: Introductionmentioning

confidence: 99%

Stability of Metronidazole and Its Complexes with Silver(I) Salts under Various Stress Conditions

et al. 2021

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Metronidazole is a drug widely used in the prevention and treatment of bacterial infections. Due to its possibility of the formation of stable metal complexes, it was decided to broaden its activity spectrum by introducing the silver(I) coordination compounds i.e., [Ag(MTZ)2NO3] and [(Ag(MTZ)2)2]SO4, which have significant antibacterial properties. The paper presents a description of a new qualitative and quantitative analysis of metronidazole in bulk and possible pharmaceutical preparations by thin-layer chromatography with densitometric detection. Optimal separation conditions were selected, and the analytical procedure was validated according to the ICH guidelines. The obtained data indicate that the method is sufficiently sensitive, precise, and accurate. The stability of the metronidazole solutions obtained from tablets, pure metronidazole, and its silver(I) complexes was tested. The research was carried out in various environments, at different temperatures, in H2O2 solution, and during exposure to radiation (UV, sunlight). The greatest degradation was found in the alkaline environment and at higher temperatures. The silver(I) complexes exhibited relatively high stability under analyzed conditions that are higher than standard metronidazole solutions and tablets. The observations were confirmed by the kinetic and thermodynamic analysis. The described studies of new metronidazole silver(I) complexes increase the potential for their application in infections both in humans and animals.

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Section: Introductionmentioning

confidence: 99%

Stability of Metronidazole and Its Complexes with Silver(I) Salts under Various Stress Conditions

et al. 2021

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“…Different spectrophotometric methods have been published for determining MTR in different pharmaceutical preparations [6][7][8][9][10][11][12][13][14] and colorimetric [15][16][17][18][19][20]. Also it was determined by spectrofluorimetric [21], voltammetric [22], and different chromatographic methods: HPLC [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42], TLC [39,43] and gas chromatography [23].…”

Section: Introductionmentioning

confidence: 99%

Different chromatographic methods for simultaneous determination of diloxanide furoate, metronidazole and its toxic impurity

et al. 2016

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“…9, 2012 an unbroken chain of calibrations, each contributing to the measurement uncertainty, 15,16 and is a requirement for accredited laboratories under ISO/IEC 17025:2005. 17 Even if in several fields the use of CRMs is a well-established practice, in the pharmaceutical area only a few are available, including four CRMs from the United States Pharmacopeial Convention (USP), 18 17β-estradiol CRM from the National Metrology Institute of Japan (NMIJ), 19 paclitaxel CRM from the National Metrology Institute of China (NIM), 20 as well as the CRMs of captopril, 21,22 metronidazole 23 and sodium diclofenac from the National Institute of Metrology, Quality and Technology (INMETRO, Brazil).…”

Section: Introductionmentioning

confidence: 99%

Determination of volatiles in pharmaceutical certified reference materials

Nogueira¹,

Queiroz²,

Silva³

et al. 2012

J. Braz. Chem. Soc.

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Este trabalho compara os resultados obtidos na determinação de voláteis (água e solventes residuais) em novos materiais de referência certificados (MRC) ou candidatos a MRC dos ingredientes ativos farmacêuticos (API) captopril, metronidazol, diclofenaco sódico, diclofenaco potássico e furosemida, através do uso de diferentes técnicas: perda por dessecação (LOD), titulação coulométrica tipo Karl Fisher (KF), cromatografia gasosa (injeção por headspace estático) com detector por ionização em chama (sHS-GC-FID) e com espectrômetro de massas (sHS-GC-MS), análise termogravimétrica (TGA) e espectroscopia no infravermelho próximo (NIR) com análise estatística multivariada dos resultados. As três primeiras técnicas levaram a resultados complementares na determinação de voláteis, enquanto as outras duas mostraram pouca sensibilidade para a determinação de voláteis na faixa de concentração avaliada. A perda por dessecação foi considerada a técnica mais apropriada para determinação da fração mássica de voláteis a ser utilizada no cálculo do teor de API por balanço de massa.This work compares the results obtained for the determination of volatiles (water and residual solvents) in new certified reference materials (CRM) or candidate CRMs of the active pharmaceutical ingredients (API) captopril, metronidazole, sodium diclofenac, potassium diclofenac and furosemide, by means of different techniques: loss on drying (LOD), Karl Fischer (KF) coulometric titration, static headspace gas chromatography with flame ionization detection (sHS-GC-FID) and with mass spectrometry (sHS-GC-MS), thermogravimetric analysis (TGA) and near infrared spectroscopy (NIR) with multivariate chemometric analysis of results. The first three methods led to complementary results. The two other techniques were not sufficiently sensitive to determine volatiles in the concentration range evaluated. The loss on drying method was considered the most appropriate to determine the mass fraction of the volatiles to be used in the mass balance calculation of the API mass fraction in the pharmaceutical CRMs.Keywords: volatiles, water, residual solvents, active pharmaceutical ingredient (API), certified reference materials (CRM), analytical quality control IntroductionSeveral are the reasons for determining the mass fractions of water and residual solvents in pharmaceuticals, including their influence on the physicochemical 1-7 and microbiological stability of raw materials and finished products, their potential toxicity [1][2][3]8 and also economic aspects 9 since their presence results in analyte mass fractions smaller than 100%. Residual solvents may be introduced in active pharmaceutical ingredients (API) during their synthesis, especially if the final purification step is carried out by crystallization in different solvents, as well as during drug products formulation and manufacturing. 1,7,8 In the particular case of certified reference materials (CRM) of APIs, the determination of volatiles is essential both to demonstrate the compliance with Pharmacopeial acc...

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Development studies of a new metronidazole certified reference material

Cited by 4 publications

References 15 publications

Stability of Metronidazole and Its Complexes with Silver(I) Salts under Various Stress Conditions

Stability of Metronidazole and Its Complexes with Silver(I) Salts under Various Stress Conditions

Different chromatographic methods for simultaneous determination of diloxanide furoate, metronidazole and its toxic impurity

Determination of volatiles in pharmaceutical certified reference materials

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