Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND DACLATASVIR IN BULK AND TABLET DOSAGE FORM BY USING RP-HPLC IN BIORELEVANT DISSOLUTION MEDIA

Parameshwar Aleti*, Agaiah Goud Bairi, Karnaker Reddy Yalla, Kumara Swamy Samanthula

ABSTRACT

This study aimed to develop sofosbuvir and daclatasvir acid marketed formulation and to develop a stability-indicating HPLC method for their simultaneous estimation of sofosbuvir and daclatasvir acid in pure forms and in its final dosage forms in bio relevant media as per ICH guidelines. An isocratic mode HPLC method was performed; the flow rate was 1.0 ml/min, injected volume 10μL, and the mobile phases consisted of 50% phosphate buffer 3 pH and 50% acetonitrile, and UV detection was carried out at 238nm. Sofosbuvir and daclatasvir acid and their combined dosage form were exposed to thermal, oxidative, and acid-base hydrolytic stress conditions and the stressed samples were analyzed. The method's linearity, precision, accuracy, system appropriateness, and robustness were all validated. The method utilized is specific for estimating sofosbuvir and daclatasvir acid in the presence of degradation products and contaminants. The method was linear over the range of 80-400 μg/mL and 20-100μg/mL for sofosbuvir and daclatasvir acid, respectively. The mean recoveries for the accuracy studies were found to be within limits for sofosbuvir and daclatasvir acid, respectively. The per cent of standard deviation value (% RSD) was discovered to be less than the critical value. Our devised analytical approach is a stability-indicating, cost-effective, and relevant method that can be used to control the quality of sofosbuvir and daclatasvir acid in medicinal tablet formulations.

Keywords: Sofosbuvir and Daclatasvir acid, ICH, Biorelevant Media, Hepatitis C Virus, Validation.