Abstract

VALIDATED CAPILLARY ZONE ELECTROPHORESIS APPROACH FOR SIMULTANEOUS SEPARATION AND DETERMINATION OF HEPATITIS C SOFOSBUVIR AND LEDIPASVIR IN TABLET DOSAGE FORM

Abdulkareem Abdulraheem and Maha F. El-Tohamy†*

Abstract

Our strategy in this study concerned with the development of a simple, highly sensitive and precise capillary zone electrophoresis method for the simultaneous separation and quantification of hepatitis C drugs sofosbuvir and ledipasvir in pure forms and their combined tablets. Under optimum electrophoretic conditions fused silica capillary of 57 and 50 μm i.d. total length and effective length, respectively was applied for the separation of the selected drugs using 20 mmol L-1 acetate buffer pH = 4 as ground electrolyte and the running potential 25 kV with hydrodynamic injection 5 s and 70 mbar pressure. The temperature was adjusted at 25˚C and the diode array detection was carried out at 260 nm. Daclatasvir was used as internal standard. The electrophoretic separation was performed over the linear relationship of 5-600 and 20-400 μg mL-1 with correlation coefficients of 0.9995 and 0.9997 for sofosbuvir and ledipasvir, respectively. Excellent quantification/detection ratios of 5/1.5 and 20/6.0 μg mL-1 were obtained for sofosbuvir and ledipasvir, respectively. The method was validated to ensure its suitability using ICH guidelines.

Keywords: Sofosbuvir, Ledipasvir, Hepatitis C, Pharmaceutical formulations, Capillary zone electrophoresis.