Abstract

A NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND DACLATASVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

B. Sumana*, A. Rajamani, A. Yasodha and Rizwana Begum

ABSTRACT

A Novel Analytical simple, reproducible and efficient RP-HPLC method was developed for simultaneous estimation of Sofosbuvir and Daclatasvir in pure form and marketed combined pharmaceutical dosage forms. A column having Develosil ODS HG-5 RP C18, 15cmx4.6mm, i.d. Column in isocratic mode with mobile phase containing Methanol: Acetonitrile in the ratio of 85:15% v/v was used. The flow rate was 1.0 ml/min and effluent was monitored at 258nm. The retention times and linearity range for Sofosbuvir and Daclatasvir was found to be (2.217, 5861min) and (0-14, 0-28), respectively. The method has been validated for linearity, accuracy and precision, robustness and limit of detection and limit of quantitation. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.08μg/ml and 0.24μg/ml for Sofosbuvir and 0.1μg/ml 0.3μg/ml for Daclatasvir respectively. The proposed method was found to be accurate, precise and selective for the simultaneous estimation of Sofosbuvir and Daclatasvir in pure form and marketed combined pharmaceutical dosage forms.

Keywords: Sofosbuvir and Daclatasvir, RP-HPLC, Validation, Accuracy, Precision.