RP-HPLC Method Development and Validation for the Simultaneous Determination of Avelumab and Axitinib
DOI:
https://doi.org/10.47957/ijpda.v13i2.627Keywords:
RP-HPLC, Development, Validation, Avelumab and AxitinibAbstract
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Avelumab and Axitinib in pharmaceutical dosage form. Chromatographic separation of Avelumab and Axitinib was achieved on Waters Alliance-e2695 by using Inertsil ODS (250x 4.6mm, 5µ) column and the mobile phase containing Acetonitrile: 0.1% Formic acid in the ratio of 40:60% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 272nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Avelumab and Axitinib were NLT 2000 and should not more than 2 respectively. The % Relative standard deviation of peak areas was always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Avelumab and Axitinib study of its stability.
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Smith K, Garman L, Wrammert J, Zheng NY, Capra JD, Ahmed R, Wilson PC. Rapid generation of fully human monoclonal antibodies specific to a vaccinating antigen. Nature protocols. 2009 Mar;4(3):372-84.
Ho M, Feng M, Fisher RJ, Rader C, Pastan I. A novel high?affinity human monoclonal antibody to mesothelin. International Journal of Cancer. 2011 May 1;128(9):2020-30.
Emge DA, Cardones AR. Updates on Merkel cell carcinoma. Dermatologic clinics. 2019 Oct 1;37(4):489-503.
Sunshine JC, Jahchan NS, Sage J, Choi J. Are there multiple cells of origin of Merkel cell carcinoma?. Oncogene. 2018 Mar 15;37(11):1409-16.
Punyavoravut V, Nelson SD. Diffuse bony metastasis from transitional cell carcinoma of urinary bladder: a case report and review of literature. Journal of the Medical Association of Thailand= Chotmaihetthangphaet. 1999 Aug 1;82(8):839-43.
Colin P, Koenig P, Ouzzane A, Berthon N, Villers A, Biserte J, Rouprêt M. Environmental factors involved in carcinogenesis of urothelial cell carcinomas of the upper urinary tract. BJU international. 2009 Nov;104(10):1436-40.
Syn NL, Teng MW, Mok TS, Soo RA. De-novo and acquired resistance to immune checkpoint targeting. The Lancet Oncology. 2017 Dec 1;18(12):e731-41.
Boss A, Clasen S, Kuczyk M, Schick F, Pereira PL. Image-guided radiofrequency ablation of renal cell carcinoma. European radiology. 2007 Mar;17:725-33.
Gurusamy K, Vale CL, Pizzo E, Bhanot R, Davidson BR, Mould T, Mughal M, Saunders M, Aziz O, O'Dwyer S. Cytoreductive surgery (CRS) with hyperthermic intraoperative peritoneal chemotherapy (HIPEC) versus standard of care (SoC) in people with peritoneal metastases from colorectal, ovarian or gastric origin: protocol for a systematic review and individual participant data (IPD) meta-analyses of effectiveness and cost-effectiveness. BMJ open. 2020 May 1;10(5):e039314.
M. Vijaya Kumari, Ch. Balasekhara Reddy, P. Eswaramma. Analytical Method Development and Validation of Avelumab and Axitinib in Bulk and Pharmaceutical Dosage Form by RP-HPLC: International Journal of Pharmacy & pharmaceutical Research, May 2023, 27, 2.
Surendra Babu Lagu, Ramanamma Lalam, Baratam Sandhya Rani. New method development and validation for the simultaneous estimation of Avelimab and Axitinib by using RP-HPLC: Journal of Pharmaceutical Advanced Research J Pharm. Adv Res, 2023; 6(12): 2033-2038.
K. Nithiyananthan and KVS. Prasada Rao, validation of stability indicating rp-hplc method for simultaneous estimation of axitinib and avelumab by using analytical quality by design (aqbd) method: International Journal of pharmaceutical Science and Research,IJPSR (2024), 15, 3.
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