Author(s): Swarna Sree P, Poojitha K, Zoya Tanweer S K, Sneha S, Sai Kiran V, Alapati Sahithi, Shanthi Priya D.K

Email(s): shanthipriyapharmacy@anurag.edu.in

DOI: 10.52711/0974-360X.2026.00299   

Address: Swarna Sree P1, Poojitha K1, Zoya Tanweer S K1, Sneha S1, Sai Kiran V2, Alapati Sahithi3, Shanthi Priya D.K1*
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

Published In:   Volume - 19,      Issue - 5,     Year - 2026


ABSTRACT:
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 430C 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.


Cite this article:
Swarna Sree P, Poojitha K, Zoya Tanweer S K, Sneha S, Sai Kiran V, Alapati Sahithi, Shanthi Priya D.K. Stability Indicating UPLC Method Development and Validation for Quantitative Estimation of Sarilumab. Research Journal Pharmacy and Technology. 2026;19(5):2082-8. doi: 10.52711/0974-360X.2026.00299

Cite(Electronic):
Swarna Sree P, Poojitha K, Zoya Tanweer S K, Sneha S, Sai Kiran V, Alapati Sahithi, Shanthi Priya D.K. Stability Indicating UPLC Method Development and Validation for Quantitative Estimation of Sarilumab. Research Journal Pharmacy and Technology. 2026;19(5):2082-8. doi: 10.52711/0974-360X.2026.00299   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-5-20


REFERENCES:
1.    Conforti A, Di Cola I, Pavlich V, Ruscitti P, Berardi Curti O, Ursini F, Giacomelli R, Cipriani P. Beyond the joints, the extra-articular manifestations in rheumatoid arthritis. Autoimmunity Reviews. 2021 Feb 1; 20(2): 102735. 
2.    Firestein GS. Evolving concepts of rheumatoid arthritis. Nature. 2003 May 15; 423(6937): 356-61.
3.    Kaufman MB. Pharmaceutical Approval Update. P T. 2017 Sep; 42(9): 562-580. PMID: 28890641; PMCID: PMC5565128.
4.    Smolen JS, Van Der Heijde D, Machold KP, Aletaha D, Landewé R. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Annals of the Rheumatic Diseases. 2014 Jan 1; 73(1): 3-5.
5.    Huizinga TW, Fleischmann RM, Jasson M, Radin AR, van Adelsberg J, Fiore S, Huang X, Yancopoulos GD, Stahl N, Genovese MC.Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Annals of the rheumatic diseases. 2014 Sep 1; 73(9): 1626-34.
6.    Moretz D, Page J. Drug Class Update: Biologics for Autoimmune Conditions.
7.    Sasani MS, Moradi Y. Role of Recombinant Proteins for Treating Rheumatoid Arthritis. Avicenna Journal of Medical Biotechnology. 2024; 16(3): 137.
8.    FDA Approved Drug Products: KEVZARA (sarilumab) injection for subcutaneous use (February 2023
9.    Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, Bryson J, Duncan B, Zhu W, Pitzalis C, Durez P. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Annals of the rheumatic diseases. 2014 Sep 1; 73(9): 1607-15.
10.    Remap-Cap Investigators. Interleukin-6 receptor antagonists in critically ill patients with Covid-19. New England Journal of Medicine. 2021 Apr 22; 384(16): 1491-502.
11.    Sivapalasingam S, Lederer DJ, Bhore R, Hajizadeh N, Criner G, Hosain R, Mahmood A, Giannelou A, Somersan-Karakaya S, O’Brien MP, Boyapati A. Efficacy and safety of sarilumab in hospitalized patients with coronavirus disease 2019: a randomized clinical trial. Clinical Infectious Diseases. 2022 Jul 1; 75(1): 380-8.
12.    Alumuri T, Merugu K, amarababu NL, Kurnool A. Peramivir and related impurities in rat plasma and its applications in pharmacokinetic studies (bioanalytical method development and validation by LC-MS/MS). Int J App Pharm. 2022; 14(5): 53-61.
13.    Guideline IH. Validation of analytical procedures: text and methodology. Q2 (R1). 2005 Nov;1(20):05.
14.    McDowall RD.The role of laboratory information management systems (LIMS) in analytical method validation. Analytica Chimica Acta.1999 May; 391: 149–158.
15.    Wood R. How to Validate Analytical Methods. Trends in Analytical Chemistry. (2005).
16.    ICH Validation of analytical procedures: Text and methodology, Q2 (R1), International Conference on Harmonization (2005). 
17.    Annapurna MM, Shanthi Priya D K. Stability indicating RP-UPLC method for the simultaneous estimation of
18.    Niraparib and Abiraterone in pharmaceutical dosage forms. Research J. Pharm. and Tech. 2024; 17(2): 910-4.
19.    Vasu Babu P, Akila Devi D. Stability Indicating Assay Method Development and Validation by RP-UPLC with PDA detector for Simultaneous Estimation of Glycopyrrolate and Neostigmine in Pharmaceutical dosage form. Research J. Pharm. and Tech. 2023; 16(7): 3219-2.
20.    B.R.K., Addanki, S. Novel Stability-Indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical formulations. Future J Pharm Sci.7, 86 (2021).
21.    Twinkle S, Monika B, Anamik S. Development of a Stability-indicating RP-UPLC Method for determination of Fidarestat in Bulk Drug. Research J. Pharm. and Tech. 2022; 15(7): 3173-8.
22.    Shanthi Priya D K , Annapurna M M. Stability indicating RP-HPLC method for the simultaneous estimation of Olaparib & Bevacizumab in pharmaceutical dosage forms. Research J. Pharm. and Tech. 2024; 17(2): 5885-9.
23.    M. Sindhu, Mohammed Farana, M. Bhavani, Santhoshi Priya Dandamudi,Shanthi Priya D K, Vasudha Bakshi Stability Indicating RP-HPLC Method for Simultaneous Estimation of Nirmatrelvir and Ritonavir in Bulk and Tablets. Research J. Pharm. and Tech. 2025; 18(2): 594-8.
24.    Poojari Venkatesh, Umasankar Kulandaivelu, GSN Koteswara Rao, Guntupalli Chakravarthi, Rajasekhar Reddy Alavala, Bandlamuri Rajesh. Development and validation of a stability indicating UPLC method for determination of Darolutamide in its tablet formulation. Research J. Pharm. and Tech 2022; 15(1): 165-170.
25.    S. Madhavi, A. Prameela Rani.Development and validation of RP-UPLC method for simultaneous estimation of Cobicistat and Darunavir. Research J. Pharm. and Tech. 2017; 10(12): 4343-4349
26.    ICH Q1A (R2) Stability testing of new drug substances and products (2003).

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.52711/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available