Development and Validation of Stability Indicating Rp-Hplc Method for the Simultaneous Estimation of Sofosbuvir and DaclatasvirDihydrochloride in Bulk Drug and Pharmaceutical Dosage Form
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2018, Vol 4, Issue 5
Abstract
Abstract:A new stability indicating RP-HPLC method was developed and validated for the simultaneous estimation of Sofosbuvir and Daclatasvir in pharmaceutical dosage form and bulk drug. The optimized conditions for the simultaneous estimation of drug includes Discovery C18 (150mm x 4.6 mm, 5m) column, 0.01N potassium dihydrogen phosphate and Acetonitrile (50:50%v/v) as mobile phase run on isocratic mode at a flow rate 1.0ml/min. The column is maintained at 30ºC temperature and the drugs are detected at a wavelength of 254nm. The retention time for Sofosbuvir and for Daclatasvir were found to be 2.47 min and 3.31 min respectively. The %RSD for Sofosbuvir and Daclatasvir were found 0.8 and 0.5 respectively. The % Recovery for Sofosbuvir was found to be 99.90% - 100.03% and % recovery for Daclatasvir was found to be 99.90% - 99.93%. A linear response was found in the concentration range of 100µg/ml – 600µg/ml for Sofosbuvir and 15µg/ml – 90µg/ml for Daclatasvir, with correlation coefficient of 0.999 for both the drugs. The method was found to specific, accurate, precise, robust, rugged and stable in solution for 24 hours. The forced degradation studies indicated that the drugs are stable in various stress conditions as the net degradation was found to be within the limits. The developed method can be used for the quality control for simultaneous estimation of Sofosbuvir and Daclatasvir in pharmaceutical dosage form. Keywords:Sofosbuvir, Daclatasvir, Stability indicating, Method development, Validation, RP-HPLC.
Authors and Affiliations
Jahnavi Bandla, S Ganapaty
Keywords
Related Articles
- EP ID EP397572
- DOI -
- Views 113
- Downloads 0
Assessment of Type and Severity of Road Traffic Accident Injuries among Omani Young Adults
Abstract: It was carried out to evaluate and assess types of injuries in road traffic accident and their severity reported to one of the tertiary care hospital through cross sectional systemic prospective and retrospecti...
Task Shifting: A Need for Current Health Care System
Abstract: World is facing a crisis in human health resources due to a critical shortage of health workers. Despite of many trained health care professionals our health care system is struggling to provide optimum servic...
Assessment of Knowledge, Attitude and Practices regarding Occupational Hazards among Nurses at Nawaz Sharif Social Security Hospital Lahore Pakistan
Abstract: Occupational hazards associated with health are present in every occupation, and they are the leading cause of death and mortality. Occupational safety at the workplace improves the employees’ health and increa...
Development, Characterization & Comparative Evaluation of Nanostructured Lipid Carriers and Solid Lipid Nanoparticles for Potent Oral Delivery of Furosemide
The aim of the present study was to increase the solubility and thereby improve the oral bioavailability of Furosemide by incorporating the drug in nanostructured lipid carriers (NLC) and in solid lipid nanoparticle (SLN...
Assessment of zinc, Lipid profile and HB A1c in Sudanese with Type II Diabetes Mellitus in Khartoum State
Abstract: Type 2 diabetes mellitus is associated with increased metabolic processes and oxidative stress. The trace elements are important co-factors in these events. Thus this study was conducted to compare serum levels...