Development and validation of a simple and rapid capillary zone electrophoresis method for determination of nnrti nevirapine in pharmaceutical formulations

Abstract

Um método simples e rápido por eletroforese capilar foi desenvolvido e validado para a quantificação do inibidor não nucleosídeo da transcritase reversa (NNRTI) nevirapina, em medicamentos. A análise foi otimizada utilizando tampão fosfato de sódio 10 mmol L -1 , pH 2,5, voltagem aplicada de +25 kV, injeção hidrodinâmica a 0,5 psi por 5 s e detecção UV em 200 nm. Diazepam (50,0 µg mL -1 ) foi usado como padrão interno. Sob estas condições, nevirapina foi analisada em aproximadamente menos de 2,5 min. A curva analítica apresentou um coeficiente de correlação de 0,9994. Os limites de detecção e quantificação foram 1,4 µg mL -1 e 4,3 µg mL -1 , respectivamente. Precisões intra e inter-dia expressas como desvio padrão relativo foram 1,4% e 1,3%, respectivamente e a recuperação média foi de 100,81%. O fármaco foi submetido a testes de hidrólises (ácida, básica e neutra) e a estresse oxidativo. Não foi observada interferência por parte dos produtos de degradação, nem dos excipients na análise da nevirapina. Este método mostrou ser rápido, simples, preciso, exato e econômico para a determinação de nevirapina em produtos farmacêuticos e é apropriado para o controle de qualidade em análise de rotina uma vez que a eletroforese capilar oferece benefícios em termos de desenvolvimento rápido dos métodos e custos muito reduzidos de operação.A simple and fast capillary zone electrophoresis (CZE) method has been developed and validated for quantification of a non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, in pharmaceuticals. The analysis was optimized using 10 mmol L -1 sodium phosphate buffer pH 2.5, +25 kV applied voltage, hydrodynamic injection 0.5 psi for 5 s and direct UV detection at 200 nm. Diazepam (50.0 µg mL -1 ) was used as internal standard. Under these conditions, nevirapine was analyzed in approximately less than 2.5 min. The analytical curve presented a coefficient of correlation of 0.9994. Limits of detection and quantification were 1.4 µg mL -1 and 4.3 µg mL -1 , respectively. Intra-and inter-day precision expressed as relative standard deviations were 1.4% and 1.3%, respectively and the mean recovery was 100.81%. The active pharmaceutical ingredient was subjected to hydrolysis (acid, basic and neutral) and oxidative stress conditions. No interference of degradation products and tablet excipients were observed. This method showed to be rapid, simple, precise, accurate and economical for determination of nevirapine in pharmaceuticals and it is suitable for routine quality control analysis since CE offers benefits in terms of quicker method development and significantly reduced operating costs.

Development, Validation and Application of a Spectrofluorimetric Method for the Quantification of Nevirapine in Pharmaceutical Formulations Tablets and Suspensions

“…Analytical methods are reported in the literature for the determination of NVP in tablets and suspensions. They employ techniques such as capillary electrophoresis [10] [11], electroanalysis [12]- [23], spectrophotometry [24]- [33], high performance liquid chromatography (HPLC) [24] [28] [34]- [63], liquid chromatography coupled with mass spectrometry LC/MS/MS [64]- [77], gas chromatography coupled with mass spectrometry (CG-MS) [78] and high performance thin layer chromatography (HPTLC) [58] [79]. The International Pharmacopoeia, USP, British and European Pharmacopoeia have adopted the HPLC method for the quantitative analysis of nevirapine in formulations [80] [81] [82] [83].…”

Insights into the Design of An Enzyme Free Sustainable Sensing Platform for Efavirenz

“…For the measurement of EFV, different analytical tests have been established, including chromatographic [1,[4][5][6][7][8][9][10][11], spectrophotometric methods [2,12], and electrophoresis [13,14]. These assays, on the other hand, are expensive and necessitate lengthy and arduous experimental procedures, solvent extraction, sample pre-treatment, optimized instruments, and a qualified analyst [3,15].…”