1School of Pharmacy, Anurag University, Hyderabad, India
2Seniour Associate Scientist, Syngene Interntional Limited, Shamirpet, Hyderabad, India
3School of Pharmacy, Nalla Narasimha Reddy Educational Society’s Group of Institutions, Medchal(D), Hyderabad, 500076, India
*Corresponding Author E-mail: shanthipriyapharmacy@anurag.edu.in
An effective method of UPLC has been used to develop and validate the drug sarilumab which is a monoclonal antibody belonging to class biosimilars to treat autoimmune disorders like rheumatoid arthritis. The method uses an Acuity UPLC CSH C18 column with UV detection at 212nm and offers rapid results, with Sarilumab eluting at 0.819 minutes within a runtime of 2 minutes. The column is maintained under a stable temperature of 43°C with a flow rate of 0.5ml/ minute. The method is extremely reliable as it has a clear linear relationship between concentration and response from the range of 10-60μg/mL The equation for linearity was determined to be y=14130x+3582. The method is also sensitive as the LOD was 0.57μg/mL and LOQ was 1.72μg/mL. The method can be used for regular quality control of Sarilumab in pharmaceutical applications because it is rapid, accurate, and sensitive.
Sarilumab, UPLC, Validation, Forced degradation studies, ICH guidelines
