Chromatogram 1- Fidaxomicin LLOQ (50 pg/ml) overlay on Blank Plasma Sample

Bio-Analytical SPE Method For Quantitative Estimation

of Fidaxomicin

LC/MS method for quantitative Estimation of Fidaxomicin, and it’s metabolite OP-1118 from Human K2 EDTA plasma samples

LC/MS-MS Assay method was developed and validated for estimation of plasma levels of Fidaxomicin and it’s metabolite OP-1118 with LLOQ of 50 pg/ml and 0.2 ng/ml respectively. Method is successfully applied for performing sample analysis of Bioequivalence studies of Fidaxomicin 200 mg tablets.

FIDAXOMICIN

Graph-1, Calibration curve, Fidaxomicin

Chromatogram 2- OP-1118 LLOQ (0.2 ng/ml) overlay on Blank Plasma sample

Graph-2, Calibration curve, OP-1118