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Middle East Journal of Digestive Diseases، جلد ۱۶، شماره ۲، صفحات ۹۶-۱۰۱
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عنوان انگلیسی A Quick and Sensitive LC-MS/MS Method for Simultaneous Quantification of Sofosbuvir Metabolite (GS-331007) in Human Plasma: Application to Hepatitis C Infected Patients with End Stage Renal Disease
چکیده انگلیسی مقاله Background: Sofosbuvir (SOF) is a revolutionary treatment for patients with hepatitis C virus (HCV). However, its efficacy and safety among patients with end-stage renal disease (ESRD) remains controversial. In this study, we examined the levels of SOF metabolite (GS-331007) (SOF-007) in human plasma of patients infected with HCV having ESRD using an optimized liquid Chromatography-Mass Spectrometry (LC-MS) analytical method. Methods: In this case-control study, 10 clinically confirmed cases and five controls were enrolled. SOF-007 was extracted from plasma using methanol precipitation. The limit of detection (LOD) for the drug and its metabolite were 0.85 and 2.3, respectively. Such a wide range of quantification in a period of separation time shorter than 3.0 min (run time) allowed monitoring of the plasma concentration of analytes up to 4 h (pre-dialysis and post-dialysis) for 12 weeks in non-cirrhotic patients with HCV infection undergoing dialysis.  Results:  SOF-007 in the plasma of HCV patients with healthy kidneys showed no cumulative effect. An analysis comparing patients with ESRD and healthy participants showed that their behaviour was similar, followed by dialysis with a relatively small cumulative effect. Conclusions : The plasma concentrations of SOF-007 decreased significantly after the 4-h period of dialysis compared with the plasma concentrations hemodialysis of pre-dialysis in HCV patients with ESRD.
کلیدواژه‌های انگلیسی مقاله Sofosbuvir,SOF metabolites,UPLC-MS/MS,Validation,Hepatitis C,Hemodialysis
نویسندگان مقاله | Sara Majd Jabbari
Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran


| Maryam Dibaie
Department of Epidemiology and Biostatistics, School of Public Health, Tehran university of Medical Sciences, Tehran, Iran


| Khadije Maajani
Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran


| Shahin Merat
Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran


| Sadaf G. Sepanlou
Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran


| Mohammad R. Rouini


نشانی اینترنتی http://mejdd.org/index.php/mejdd/article/view/2944
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