Stress stability study of simeprevir, a hepatitis C virus inhibitor, using feasible TLC-spectro-densitometry: application to pharmaceutical dosage form and human plasma

Abstract

Simeprevir is one of the newest direct action anti-hepatitis C drugs.

Identification, isolation, structural characterization, in silico toxicity prediction and in vitro cytotoxicity assay of simeprevir acidic and oxidative degradation products

“…The degradation behaviour of simeprevir was studied according to the ICH guidelines, and the drug was found to be unstable to acidic and oxidative conditions and stable under alkaline and thermal degradation conditions, as shown in Table 2. Although, previous reports by Attia et al 18 and Mohammed et al 27 uses different basic hydrolysis conditions; 0.1 N NaOH for 3 hours at room temperature and 1 M NaOH for 2 hours at 60 C; respectively. Both results were found to be similar where one degradation product was observed with almost same degradation percentage (35.55% and 39.80%).…”

Application of different spectrophotometric methods for quantitative analysis of direct acting antiviral drugs simeprevir and sofosbuvir

“…The literature review of SMV [9] , [10] , [11] , [12] , [13] and SFV [14] , [15] , [16] , [17] , [18] revealed few published methods for determination of the drugs individually. There were only two published methods for the simultaneous determination goal [19] , [20] .…”