Abstract

A STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK BY RP-HPLC

Nelapati Yajjari, Karavadi Thejomoorthi* and Ch. Sai Babu

ABSTRACT

A new, simple, precise, accurate and reproducible RP-HPLC method for stability indicating method development and validation of Ledipasvir and Sofosbuvir in bulk form. Separation of Ledipasvir and Sofosbuvir was successfully achieve Dona Zorbax C8, 250 X4.6, 5μm or equivalent in an isocratic mode utilizing 0.1% OPA: Methanol (45:55) at a flow rate of 1.0mL/min and eluate was monitored at 238nm, with a retention time of 3.296 and 7.257minutes for Ledipasvir and Sofosbuvir respectively. The method was validated and their response was found to be linear in the drug concentration range of 45μg/ml to135 μg/ml for Ledipasvir and 200μg/ml to 600 μg/ml for and Sofosbuvir. The values of the correlation coefficient were found to 0.999 for Ledipasvir and 1 for Sofosbuvir respectively. The LOD and LOQ for Ledipasvir were found to be 0.090 and 0.695 respectively. The LOD and LOQ for Sofosbuvir were found to be 0.6619 and 2.2063 respectively. This method was found to be good percentage recovery for Ledipasvir and Sofosbuvir were found to be 100 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precession, Specificity and Robustness.

Keywords: Ledipasvir, Sofosbuvir, High performance liquid chromatography, Stability-indicating.