Development and validation of an electroanalytical methodology for determination of isoniazid and rifampicin content in pharmaceutical formulations

Abstract

Tuberculosis remains a major public health problem, especially in developing countries. Brazil presents the largest number of cases in Latin America and is among the 22 countries considered priorities by the World Health Organization (WHO). The Rio de Janeiro state has the largest number of cases registered in the country. The treatment of patients, commonly, makes use of the drugs isoniazid and rifampicin for six months. This study aimed to develop and validate an electroanalytical methodology, using the technique of differential pulse voltammetry for the determination of these drugs in the associated form, in order to evaluate the quality of medicines distributed in the state of Rio de Janeiro. The potential reduction for the isoniazid and rifampicin were -1.10 and -0.90 V. The developed and validated electroanalytical method presented a linear range of 0.25 to 1.25 mg/L to isoniazid, limits of detection and quantification of 0.05 and 0.14 mg/L, and recovery of 98.2 ± 0.4%; a tracking linear of 0.40 to 2.00 mg/L for rifampicin, with limits of detection and quantification of 0.07 and 0.19 mg/L and recovery of 95.8 ± 0.6%. Six lots of medicines from two pharmaceutical companies were analyzed. Only one of the samples showed unsatisfactory levels of rifampicin.Uniterms: Isoniazid. Rifampicin. Tuberculosis/treatment. Tuberculostatics/quantitative analysis. Differential pulse voltammetry.A tuberculose continua sendo um importante problema de saúde pública, especialmente em países em desenvolvimento. O Brasil apresenta o maior número de casos da América Latina, estando entre os 22 países considerados prioritários nas ações de controle da doença pela Organização Mundial da Saúde (OMS). No Brasil, o Rio de Janeiro é o estado com o maior número de casos registrados no país. O tratamento de doentes com tuberculose faz uso dos fármacos isoniazida e rifampicina durante seis meses. O presente trabalho objetivou desenvolver e validar metodologia eletroanalítica, utilizando a técnica de voltametria de pulso diferencial, para a determinação desses dois princípios ativos na forma associada e avaliar a qualidade dos medicamentos distribuídos no estado do Rio de Janeiro. Os potenciais de redução para a isoniazida e rifampicina foram respectivamente -1,10 e -0,90 V. O método eletroanalítico desenvolvido e validado apresentou para a isoniazida faixa linear de 0,25 a 1,25 mg/L, limites de detecção e quantificação de 0,05 e 0,14 mg/L e recuperação de 98,2 ± 0,4%; para a rifampicina faixa linear de 0,40 a 2,00 mg/L, limites de detecção e quantificação de 0,07 e 0,19 mg/L e recuperação de 95,8 ± 0,6%. Foram analisados 6 lotes de medicamentos de dois laboratórios farmacêuticos. Apenas uma das amostras apresentou teor de rifampicina insatisfatório.Unitermos: Isoniazida/determinação. Rifampicina/determinação. Tuberculostáticos/análise quantitativa. Tuberculose/tratamento. Voltametria de pulso diferencial/utilização.

Electrochemical Determination of Rifampicin Based on Its Oxidation UsingMultiwalled Carbon Nanotubes Modified Glassy Carbon Electrode

“…The results of RIF obtained in the direction of reduction in Table 3 showed that the wider linear range was in this study compared to the studies in the literature. 21,37,38 Although carbon paste electrode gave a wider linear range in 22 , LOD value was higher than in this study. In 36 , there was no information about the linear range and the value of LOD was at the nM level as in this study.…”

“…In 36 , there was no information about the linear range and the value of LOD was at the nM level as in this study. The detection limits of the other studies in Table 3 37,38 were higher compared MWCNT/GC electrode in this study.…”

State of the Art on Developments of (Bio)Sensors and Analytical Methods for Rifamycin Antibiotics Determination

“…The anti-TB treatment very often involves the administration of RIF together with other drugs, like ISN and PYR. Therefore, the selectivity and the sensitivity of analytical methods are compulsory features for simultaneous determination of the drugs in both pharmaceuticals and more complex matrices, like biological samples [ 18 , 56 , 68 , 69 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 ]. RIF bioavailability and, therefore, its therapeutic action can be influenced by its physical or chemical interactions with other molecules (peptides, DNA, drugs, nutrients, etc.).…”

“…RIF cathodic behavior was investigated and exploited in qualitative analysis using mercury electrodes such as DME [ 70 ], SMDE [ 34 ] and HMDE [ 25 , 56 , 83 , 104 ]. RSV quantification by adsorptive stripping voltammetry at HMDE was also reported [ 105 ].At mercury electrodes, RIF voltammograms presented two peaks assigned to the irreversible reduction of the azomethine (−C=N−) functional group from the side chain of the 3-[(4-methyl-1-piperazinyl) imino] methyl moiety, which is more easily reducible and generates the more intense signal observed at less negative potentials (~0.95 V at pH ~7.00), and of the carbonyl group (situated at ~1.20 V at pH ~7.00), respectively [ 34 , 83 ].…”

A highly sensitive and ecofriendly assay platform for the simultaneous electrochemical determination of rifampicin and isoniazid in human serum and pharmaceutical formulations

“…A comparison of the prepared electrode with other reported electrodes for the simultaneous determination of RIF and INZ 42,43,[52][53][54] is summarized in Table 1. It can be seen that Ni(OH)/rGO/SPCE has a lower or similar detection limit in most cases.…”