PERAMIVIR AND RELATED IMPURITIES IN RAT PLASMA AND ITS APPLICATIONS IN PHARMACOKINETIC STUDIES (BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY LC-MS/MS)

THULASEEDHAR ALUMURI; KARUNASREE MERUGU; NAMBURI L. A. AMARABABU; ARAVIND KURNOOL

doi:10.22159/ijap.2022v14i5.45457

Authors

THULASEEDHAR ALUMURI Department of Chemistry, GITAM (Deemed to be University), Bengaluru 560034, Karnataka, India https://orcid.org/0000-0003-3841-0470
KARUNASREE MERUGU Department of Chemistry, GITAM (Deemed to be University), Bengaluru 560034, Karnataka, India
NAMBURI L. A. AMARABABU New Generation Materials Lab (NGML), Department of Science and Humanities, Vignan’s Foundation for Science Technology and Research University (VFSTR) (Deemed to be University), Vadlamudi, Guntur 522213, Andhra Pradesh, India
ARAVIND KURNOOL Department of Chemistry, Osmania University, Hyderabad 500007, Telangana, India

DOI:

https://doi.org/10.22159/ijap.2022v14i5.45457

Keywords:

Peramivir, LC-MS/MS, Development, Validation, Rat plasma

Abstract

Objective: New LC-MS/MS method for the estimation of Peramivir and its associated substances was developed and validated

Methods: Optimized (Developed) method includes gradient elution of peramivir and its related substances with a flow of 1 ml/min and waters X-bridge C₁₈ column of dimensions 150 mmx4.6 mm, 3.5µ. 0.1% formic acid and acetonitrile were used as the mobile phase. Sarilumab was used as an internal standard. 40 min run time was used to separate peramivir and its related substances.

Results: The calibration curve was linear in the concentration percentage range from 10%-200% of Peramivir and its related substances. The calibration charts plotted were linear with a regression coefficient of R²>0.999. Accuracy, precision, recovery, matrix effect and stability results were found to be within the suitable limits. A Simple and efficient method was developed and utilized in pharmacokinetic studies to see the investigated analyte in body fluids.

Conclusion: This application denotes all parameters such as accuracy, precision, recovery, stability etc, which are in good agreement with the USFDA guidelines and are effectively applied to the investigation of the pharmacokinetic studies in rat plasma.

Downloads

Download data is not yet available.

References

Hayden FG, de Jong MD. Emerging influenza antiviral resistance threats. J Infect Dis. 2011;203(1):6-10. doi: 10.1093/ infdis/jiq012, PMID 21148489.

Lindegren ML, Griffin MR, Williams JV, Edwards KM, Zhu Y, Mitchel E. Antiviral treatment among older adults hospitalized with influenza, 2006-2012. PLOS ONE. 2015;10(3):e0121952. doi: 10.1371/journal.pone.0121952, PMID 25807314.

Saunders-Hastings PR, Krewski D. Reviewing the history of pandemic influenza: understanding patterns of emergence and transmission. Pathogens. 2016;5(4):66. doi: 10.3390/pathogens5040066, PMID 27929449.

Dabestani NM, Leidner AJ, Seiber EE, Kim H, Graitcer SB, Foppa IM. A review of the cost-effectiveness of adult influenza vaccination and other preventive services. Prev Med. 2019;126:105734. doi: 10.1016/j.ypmed.2019.05.022, PMID 31152830.

Gubareva LV. Molecular mechanisms of influenza virus resistance to neuraminidase inhibitors. Virus Res. 2004;103(1-2):199-203. doi: 10.1016/j.virusres.2004.02.034, PMID 15163510.

Sugaya N. Widespread use of neuraminidase inhibitors in Japan. J Infect Chemother. 2011;17(5):595-601. doi: 10.1007/s10156-011-0288-0, PMID 21850418.

Gutierrez JA, Luo M, Singh V, Li L, Brown RL, Norris GE. Picomolar inhibitors as transition-state probes of 5′-methylthioadenosine nucleosidases. ACS Chem Biol. 2007;2(11):725-34. doi: 10.1021/cb700166z, PMID 18030989.

Schramm VL. Enzymatic transition states, transition-state analogs, dynamics, thermodynamics, and lifetimes. Annu Rev Biochem. 2011;80:703-32. doi: 10.1146/annurev-biochem-061809-100742, PMID 21675920.

Yin J, Redovich J. Kinetic modeling of virus growth in cells. Microbiol Mol Biol Rev. 2018;82(2). doi: 10.1128/MMBR.00066-17, PMID 29592895.

Blaas D. Viral entry pathways: the example of common cold viruses. Wien Med Wochenschr. 2016;166(7-8):211-26. doi: 10.1007/s10354-016-0461-2, PMID 27174165.

Fujii T, Udy A, Licari E, Romero L, Bellomo R. Sodium bicarbonate therapy for critically ill patients with metabolic acidosis: a scoping and a systematic review. J Crit Care. 2019;51:184-91. doi: 10.1016/j.jcrc.2019.02.027, PMID 30852347.

Lv L, Zhang J. The incidence and risk of infusion phlebitis with peripheral intravenous catheters: A meta-analysis. J Vasc Access. 2020;21(3):342-9. doi: 10.1177/1129729819877323, PMID 31547791.

Griffith RJ, Jordan V, Herd D, Reed PW, Dalziel SR. Vapocoolants (cold spray) for pain treatment during intravenous cannulation. Cochrane Database Syst Rev. 2016;4:CD009484. doi: 10.1002/14651858.CD009484.pub2, PMID 27113639.

Nicoll LH, Hesby A. Intramuscular injection: an integrative research review and guideline for evidence-based practice. Appl Nurs Res. 2002;15(3):149-62. doi: 10.1053/apnr.2002.34142, PMID 12173166.

Cook IF. Best vaccination practice and medically attended injection site events following deltoid intramuscular injection. Hum Vaccin Immunother. 2015;11(5):1184-91. doi: 10.1080/21645515.2015.1017694, PMID 25868476.

Richert L. Reagan, regulation, and the FDA: the US Food and Drug Administration’s response to HIV/AIDS, 1980-90. Can J Hist. 2009;44(3):467-88. doi: 10.3138/cjh.44.3.467.

Passali D, Lauriello M, Bellussi L, Passali GC, Passali FM, Gregori D. Foreign body inhalation in children: an update. Acta Otorhinolaryngol Ital. 2010;30(1):27-32. PMID 20559470.

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. IJRPS 2021;11(4):7854-62. doi: 10.26452/ijrps.v11i4.4670.

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

Ramchandran D, Kethipalli A, Krishnamurthy M. Bioanalytical 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.

Naykode MD, Bhagwat DA, Jadhav SD, More HN. Analytical and bioanalytical method for quantification of pure azilsartan, not its salts by RP-HPLC. Res J Pharm Technol. 2017;10(3):708-14. doi: 10.5958/0974-360X.2017.00133.0.

Singh M, Charde M, Shukla R, Rita MC. Determination of calcipotriene in calcipotriene cream 0.05% w/w by RP-HPLC method development and validation. Res J Pharm Technol. 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.

Shanmugasundaram P, 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 Technol. 2017;10(10):3379-85. doi: 10.5958/0974-360X.2017.00601.1.

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. Crit Rev. 2020;7:4785-90.

kumar AS, 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. Research J Pharm and Tech 2016;9:549-54.

Malak Y, Al-Bathish AA, Gazy MK, El-Jamal. Rp-HPLC and chemometric methods for the determination of two antidiabetic 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 Technol. 2013;6:200-3.

Koya Prabhakara Rao NL, A Amara Babu, Kalyani Koganti, Babji Palakeeti, Koduri SV Srinivas. Relat subst method dev validation LC-Ms/MS method for the quantification of selexipag and its related impurities in rat plasma and its application to pharmacokinetic studies. SN Applied Sciences. 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 bioanalytical validation approach of nadolol and bendroflumethiazide by LC-MS/MS on rat plasma. Int J Res Pharm Sci. 2020;11:2272-9.

Kumari GK, Kantipudi R. 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.

Rao KP, babu NL, Koganti K, Palakeeti B, Srinivas KSV. Related substances method development and validation of an LCMS/MS method for quantification of selexipag and its related impurities in rat plasma and its application to pharmacokinetic studies. SN Appl Sci. 2021;3(3):321. doi: 10.1007/s42452-021-04219-x.

Koya Prabhakara Rao, Namburi NL, A Amara Babu AA, Kalyani Koganti K, Babji Palakeeti B, Koduri SV, Srinivas KSV. Development and validation of UPLC method for separation and determination of rivaroxaban and its related substances in bulk drugs. Drug Invention Today. 2020;13:611-8.

Charu Pandya P, Sadhana Rajput J. Development and validation of stability indicating method RP-HPLC method of acotiamide. Int J Pharm Pharm Sci. 2018;10:1-8.

Athavia BA, Dedania ZR, Dedania RR, Swamy SMV, Prajapati CB. Stability indicating HPLC method for determination of vilazodone hydrochloride. Int J Curr Pharm Sci 2017;9(4). doi: 10.22159/ijcpr.2017v9i4.20975.

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. Research J Pharm and Technol. 2013;6:200-3.

Swati K, Abhishek P, Sushank S, Bothiraja C, Atmaram P. High-performance liquid chromatography for the simultaneous estimation of cefoperazone and sulbactam in rat plasma and its importance in therapeutic drug monitoring. Int J Pharm Pharm Sci. 2020;12:92-7.

Vijayakumari M, Reddy Ch B. Stability indicating validated hplc method for the determination of zanubrutinib in bulk and pharmaceutical dosage form. Asian J Pharm Clin Res. 2020;13:159-62.

Raziq A. Syed Umer Jan. Relative comparison of stability and degradation of methylcobalamin tablets of different brands at different storage settings. Int J Appl Pharm. 2021;13:171-5.

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. IJRPS 2021;12(1):708-17. doi: 10.26452/ijrps.v12i1.4167.

Prasanthi S, Himabindu G. Bıo anlaytıcal method for sımultaneous estımatıon of rıbocıclıb and letrozole and ıts applıcatıon to pharmacokınetıc studıes usıng ultra performance lıquıd chromatography. Int J Appl Pharm. 2022;14:95-102.

Syed R, Kantipudi R. Bıo-analytıcal method development and valıdatıon of avelumab, axıtınıb and ıts applıcatıon to pharmacokınetıc studıes ın rabbıt plasma by usıng LCMS/MS. Int J Appl Pharm. 2021;13:198-204.

Subba Rao Yarlagadda SR, Pavani Y, Subba Rao Mannam SR. Simultaneous method development and validation of trastuzumab and hyaluronidase-Oysk and its pharmacokinetic studies with LC-MS/MS. J Pharm Sci Res. 2020;12:375-80.

Subrahmanyam Talari S, Anuradha Vejendla A, Ratna Kumari Shetty R Kumari. Development and validation of a UPLC-MS/MS method for the simultaneous determination of verapamil and trandolapril in rat plasma: application to a pharmacokinetic study. Current Pharmaceutical Analysis. 2022;18(3):291-304. doi: 10.2174/1573412917666210302145711.

Prasanthi S, Himabindu G. Bioanalytical method for simultaneous estimation of ezetimibe and pitavastatin and its application to pharmacokinetic studies using uplc. YMERmer Journal. 2022;21(2):718-32. doi: 10.37896/YMER21.02/67.

Prasanthi S, Himabindu G. Assay of the bioanalytical method for the estimation of avelumab and aaxitinib using UPLC and its application to pharmacokinetic studies. Journal of Pharmaceutical Research International. 2022;34:1-10. doi: 10.9734/jpri/2022/v34i27A35988.