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Ann Pharm Fr ; 78(3): 217-229, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32253022

RESUMO

OBJECTIVES: In the present study, an eco- friendly micellar liquid chromatographic technique was validated for separation and quantification of two drugs; namely ribavirin (RIV), and sofosbuvir (SBV) in pure form, pharmaceuticals containing them, human plasma and human urine. These drugs are administered co-administered for treatment of Hepatitis C virus (HCV) that causes hepatitis C in humans. MATERIAL AND METHODS: These drugs were separated using Nucleosil 100-5 phenyl column. Sodium dodecyl sulphate (SDS) solution (0.05M, pH 7.0) containing triethylamine (0.3%) and n-butanol (10%) was used as a mobile phase with 1.2 mLmin-1 flow rate and 215nm detection wavelength. Nine minutes were required for resolving the two drugs from the matrix. RESULTS: The method showed good linearity for RIV and SBV with correlation coefficients (r2) more than 0.9996 within the concentration ranges of (20-400) and (40-400) ngmL-1 in pure form, (30-300) and (50-300) ngmL-1 in human plasma and (20-400) and (40-400) ngmL-1 in human urine, respectively. CONCLUSION: The recommended method was applied for examination of RIV and SBV in pure and pharmaceuticals. The obtained results were statistically matched with reported methods with no significant differences. Also, the recommended method was effectively applied for estimation of both drugs in spiked human urine and plasma without purification or extraction steps and real samples of plasma and urine of humans having therapy of RIV and SBV, as well as, performing tablets dissolution-rate tests with satisfactory results.


Assuntos
Antivirais/análise , Hepatite C/tratamento farmacológico , Antivirais/sangue , Antivirais/urina , Cromatografia Líquida de Alta Pressão/métodos , Análise Custo-Benefício , Humanos , Limite de Detecção , Reprodutibilidade dos Testes , Ribavirina/análise , Ribavirina/sangue , Ribavirina/urina , Sofosbuvir/análise , Sofosbuvir/sangue , Sofosbuvir/urina , Solubilidade
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