Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR IN TABLET DOSAGE FORM

Chintan H. Sathiya* and Sandip N. Badeliya

ABSTRACT

To develop and validate simple, precise, accurate UV-Spectrophotometric method and RP-HPLC method for the simultaneous estimation of Sofosbuvir and Ledipasvir in tablet dosage form. In UV-Spectrophotometric method, throughout the study, Methanol is used as solvent. (1) In First order derivative method the absorbance was measured for Sofosbuvir at ZCP of Ledipasvir (300.5 nm) and for Ledipasvir was at ZCP of Sofosbuvir (271 nm). RP-HPLC method was developed for determination of Sofosbuvir and Ledipasvir using C18 column (250×4.6 mm), 5μm and Phosphate buffer (pH-4): Methanol: Triethylamine (pH adjust to 4 by adding 1% o-phosphoric acid) in a volume (40:60:0.1 % v/v/v) as mobile phase and detection wavelength was 240 nm. For First order derivative method, Linearity of Sofosbuvir and Ledipasvir were found at 20-60 μg/ml and 4.5-13.5 μg/ml respectively. In RP-HPLC method, Linearity of Sofosbuvir and Ledipasvir was found at 20-60 μg/ml and 4.5-13.5 μg/ml, respectively. All mention methods, precision was found less than 2% RSD and Accuracy was found to between 98-102%. Validations of developed methods were performed according to ICH Q2 (R1) guideline.

Keywords: RP-HPLC, UV Spectrophotometry, Sofosbuvir, Ledipasvir, First order Derivative.