NEW METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK AND ITS DOSAGE FORM BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

AIM: The purpose of the present study is to develop a simple, precise, accurate, reproducible, sensitive and economical method for the determination of Ledipasvir and Sofosbuvir by RP-HPLC method, MATERIALS AND METHODS: Ledipasvir and Sofosbuvir pure drugs (API), Combination Ledipasvir and Sofosbuvir tablets (Harvoni), Distilledwater, Acetonitrile, Phosphate buffer, Methanol, Potassium di hydrogen orthophosphate buffer, Ortho-phosphoric acid. All the above chemicals and solvents are purchased from Rankem. WATERS HPLC2695SYSTEM RESULTS AND DISCUSSION: The chromatographic separation was achieved with Kromasil C-18(4.6 x 150mm, 5μm). The optimized method utilized a mobile phase of 55% 0.01N KH2PO4 and 45% Acetonitrile, with a flow rate of 1ml/min and UV Detector at 220 nm with good resolution and satisfactory plate count. Retention times were 2.402 min for Ledipasvir and 3.526 min for Sofosbuvir. The method developed was validated according to ICH guidelines where all validation parameters were within the acceptable range.