BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AVELUMAB, AXITINIB AND ITS APPLICATION TO PHARMACOKINETIC STUDIES IN RABBIT PLASMA BY USING LCMS/MS

SYED RAFI; KANTIPUDI RAMBABU

doi:10.22159/ijap.2021v13i5.42415

Authors

SYED RAFI Department of Chemistry, RVR and JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, India
KANTIPUDI RAMBABU Department of Chemistry, RVR and JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, India

DOI:

https://doi.org/10.22159/ijap.2021v13i5.42415

Keywords:

Avelumab, Axitinib, LC-MS/MS, USFDA guidelines, Rabbit plasma

Abstract

Objective: An easy, quick, precise, active and reproducible LC-MS/MS technique was developed for the bioanalytical method of Avelumab and Axitinib using Cytarabine as an internal standard.

Methods: This article summarizes the recent progress on bioanalytical LC-MS/MS methods using waters x-bridge phenyl column (150x4.6 mm, 3.5µ) column and organic mobile phase of 0.1% Tri fluoro acetic acid and Acetonitrile in 50:50 ratio.

Results: The calibration curve was linear in the range of 2-40 ng/ml for avelumab and 0.5-10 ng/ml axitnib. Accuracy, precision, recovery, matrix effect and stability results were found to be within the suitable limits. Simple and efficient method was developed and utilized in pharmacokinetic studies to see the investigated analyte in body fluids.

Conclusion: The application denotes all the parameters of system suitability, specificity, linearity and accuracy are in good agreement with USFDA guidelines and applied effectively for the investigation of pharmacokinetic studies in rabbit.

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References

Quinn DI, Lara PN. renal-cell cancer-targeting an immune checkpoint or multiple kinases. N Engl J Med 2015;373:1872–4.

Pulitzer, Melissa. Merkel cell carcinoma. Surgical Pathol Clin 2017;10:399–408.

C Lebbe, JC Becker, JJ Grob, J Malvehy, V Del Marmol, H Pehamberger, et al. Diagnosis and treatment of merkel cell carcinoma. European consensus-based interdisciplinary guideline. Eur J Cancer 2015;5:2396-403.

Beumer JH, Chu E, Salamone SJ. Body-surface area-based chemotherapy dosing: appropriate in the 21st century? J Clin Oncol 2012;30:3896–7.

D Schadendorf, C Lebbe, A ZurHausen, MF Avril, S Hariharan, M Bharmal, et al. Merkel cell carcinoma: epidemiology, prognosis, therapy and unmet medical needs. Eur J Cancer 2017;71:53-69.

PJ Allen, WB Bowne, DP Jaques, MF Brennan, K Busam, DG Coit. Merkel cell carcinoma: prognosis and treatment of patients from a single instituition. J Clin Oncol 2005;23:2300-9.

Johnston DE. Special considerations in interpreting liver function tests. Am Fam Physician 1999;59:2223–30.

P Nghiem, HL Kaufman, M Bharmal, L Mahnke, H Phatak, JC Becker. Systematic literature review of efficacy, safety and tolerability outcomes of chemotherapy regimens in patients with metastatic Merkel cell carcinoma. Future Oncol 2017;13:1263-79.

PT Nghiem, S Bhatia, EJ Lipson, RR Kudchadkar, NJ Miller, L Annamalai, et al. PD-1 blockade with pembrolizumab in advanced Merkel cell carcinoma. N Engl J Med 2016;374:2542-52.

Kwo, Paul Y, Cohen, Stanley M, Lim, Joseph K. acg clinical guideline: evaluation of abnormal liver chemistries. Am J Gastroenterol 2017;112:18–35.

Rivera Torres J, Jose ES. Src tyrosine kinase inhibitors: new perspectives on their immune, antiviral, and senotherapeutic potential. Front Pharmacol 2019;10:1011.

LJ Wilmes, MG Pallavicini, LM Fleming, J Gibbs, D Wang, KL Li, et al. AG-013736, a novel inhibitor of VEGF receptor tyrosine kinases, inhibits breast cancer growth and decreases vascular permeability as detected by dynamic contrast-enhanced magnetic resonance imaging. Magn Reson Imaging 2007;25:319-27.

B Rini, O Rixe, R Bukowski, MD Michaelson, G Wilding, G Hudes, et al. AG-013736, a multi-target tyrosine kinase receptor inhibitor, demonstrates anti-tumor activity in a phase 2 study of cytokine-refractory, metastatic renal cell cancer (RCC). J Clin Oncol 2005;23:4509.

Poulter NR, Prabhakaran D, Caulfield M. Hypertension. Lancet 2015;386:801–12.

Guagnozzi D, Lucendo AJ. Anemia in inflammatory bowel disease: a neglected issue with relevant effects. World J Gastroenterol (Review) 2014;20:3542–51.

Potturi Ramadevi, Kantipudi Rambabu. Bioanalytical method development and validation for ezetimibe and pitavastain and its applications to pharmacokinetic studies in rabbit plasma by using LCMS/MS. Int J Res Pharm Sci 2020;11:7854-62.

Asha Eluru, Surendra Babu K. Bioanalytical method development and validation for aplidine in rat plasma and their pharmacokinetic studies by LCMS. WJPPS 2019;8:1201-9.

D Ramchandran, Anita Kethipalli, Mannam Krishnamurthy. Bio analytical method development and validation of daunorubicin and cytrarabine in rat plasma by LC-MS/MS and its application in pharmacokinetic studies. J Pharm Sci Res 2020;12:381-6.

Mukta D Naykode, Durgacharan A Bhagwat, Swapnil D Jadhav, Harinath N. Analytical and bioanalytical method for quantification of pure azilsartan, not its salt by RP-HPLC. Res J Pharm Tech 2017;10:708-14.

Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita MC. Determination of calcipotriene in calcipotriene cream 0.05% w/w by RP-HPLC method development and validation. Res J Pharm Tech 2011;4:1219-23.

Malathi S, Arunadevi N. Development and validation of stability-indicating simultaneous estimation of metformin and alogliptin in tablets by high-performance thin-layer chromatography. Int J Pharm Pharm Sci 2020;12:68-73.

Senthil Rajan D, Muruganathan G, Shivkumar K, Ganesh T. Development and validation of hplc method for simultaneous quantification of vasicine, glycyrrhizin and piperine in polyherbal cough syrup. Int J Curr Pharm Res 2020;12:15-9.

Palani Shanmugasundaram, Kamarapu SK. RP-HPLC method for the simultaneous estimation and validation of amlodipine besylate and atenolol in bulk and tablet dosage form in biorelevant dissolution medium (Fassif). Res J Pharm Tech 2017;10:3379-85.

Gomathy S, Narenderan ST, Meyyanathan SN, Gowramma B. Development and validation of hplc method for the simultaneous estimation of apigenin and luteolin in commercial formulation. J Crit Rev 2020;7:4785-90.

Ashutosh Kumar S, Manidipa Debnath, Seshagiri Rao JVLN, Gowri Sankar D. Development and validation of a sensitive RP-HPLC method for simultaneous estimation of rosuvastatin and fenofibrate in tablet dosage form by using PDA detector in Gradient mode. Res J Pharm Tech 2016;9:549-54.

Malak Y, Al-Bathish AA, Gazy MK El-Jamal. Rp-hplc and chemometric methods for the determination of two anti-diabetic mixtures; metformin hydrochloride-canagliflozin and metformin hydrochloride-gliclazide in their pharmaceutical formulation. Int J Pharm Pharm Sci 2020;12:83-94.

Gadhvi MP, Bhandari A, Suhagia BN, Desai UH. Development and validation of RP-HPLC method for simultaneous estimation of atazanavir and ritonavir in their combined tablet dosage form. Res J Pharm Tech 2013;6:200-3.

Koya Prabhakara Rao, Namburi LA Amara Babu, Kalyani Koganti, Babji Palakeeti, Koduri SV Srinivas. Related substances method development and validation of an LC-MS/MS method for the quantification of selexipag and its related impurities in rat plasma and its application to pharmacokinetic studies. SN Appl Sci 2021;3:321.

Hasanah YIF, Harahap Y, Suryadi H. Development and validation method of cyclophosphamide and 4-hydroxy cyclophosphamide with 4-hydroxy cyclophosphamide-D4 as internal standard in dried blood spots using UPLC-MS/MS. Int J Appl Pharm 2021;13:148-52.

Naveen VMK, Veeraswami B, Srinivasa Rao G. High response bio analytical validation approach of nadolol and bendroflumethiazide by LC-MS/MS on rat plasma. Int J Res Pharma Sci 2020;11:2272-9.

Gowri Kusuma Kumari, Rambabu Kantipudi. Bioanalytical method development and validation for avapritinib in rat plasma by LC-MS/MS. J Pharm Sci Res 2021;13:134-7.

Hemanth Kumar AK, Sudha V, Vijayakumar A, Padmapriyadarsini C. Simultaneous method for the estimation of bidaquiline and delamanid in human plasma using high-performance liquid chromatography. Int J Pharm Pharm Sci 2021;13:36-40.

Siva Madhu Chaitanya, Srinath Nissankararao, Satya Lakshmi Gandham. A sort of validated bioanalytical method developed for the estimation of etoposide and cisplatin in rat plasma by using two different advanced liquid chromatographic techniques like HPLC and UPLC and its application in bioequivalence studies. Int J Res Pharma Sci 2021;12:708-17.