BIOANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF CLOPIDOGREL BISULFATE IN WISTAR RAT PLASMA AND ITS APPLICATION TO PHARMACOKINETIC STUDY

RAMYA SRI SURA; SUBRAHMANYAM CVS; SHYAM SUNDER RACHAMALLA

doi:10.22159/ijap.2022v14i1.43328

Authors

RAMYA SRI SURA Department of Pharmacy, University College of Technology, Osmania University, Hyderabad 500007, Telangana, India https://orcid.org/0000-0003-1660-4282
SUBRAHMANYAM CVS Gokaraju Rangaraju College of Pharmacy, Osmania University, Hyderabad 500090, Telangana, India
SHYAM SUNDER RACHAMALLA Department of Pharmacy, University College of Technology, Osmania University, Hyderabad 500007, Telangana, India

DOI:

https://doi.org/10.22159/ijap.2022v14i1.43328

Keywords:

RP-HPLC, Bioanalytical method, Clopidogrel bisulfate, Wistar rat plasma

Abstract

Objective: A novel, simple, precise, accurate, sensitive, and reproducible HPLC method for determining clopidogrel bisulfate in Wistar rat plasma was developed and validated.

Methods: The chromatographic separation was performed using Xterra C18 (250 x 4.6 mm, 5μ) column. Mobile phase composed of Acetonitrile ACN: 0.05M potassium dihydrogen orthophosphate buffer pH 4.2 and in the ratio of 75:25% v/v at a flow rate of 1.2 ml/min. Detection was carried out using a PDA detector at 220 nm. The bioanalytical clopidogrel method was validated as per ICH guidelines.

Results: The selected chromatographic condition was found to efficiently separate clopidogrel bisulfate (RT-2.838 min). The calibration curve was linear over the concentration range 40-200 ng/ml in Wistar rat plasma with a correlation coefficient of 0.999, respectively. The precision study revealed that the cumulative percentage variation was within the acceptable limit, and accuracy research showed the value of mean percent recovery between 99.72-99.83 %.

Conclusion: A simple, rapid, specific, accurate, and precise analytical method was developed and validated using Wistar rat plasma. The technique was strictly validated according to the ICH guidelines. Acquired results demonstrate that the proposed strategy can be effortlessly and advantageously applied for routine analysis of clopidogrel in the Wistar rat plasma.

Downloads

Download data is not yet available.

References

D’cruz D, Babu A, Joshy E. Bioanalytical method development and validation of ticagrelor by RP-HPLC. Int J Appl Pharm. 2017;9(3):51-4. doi: 10.22159/ijap.2017v9i3.17452.

Pravallika KE, Prameela RA, Kumar MR. Bioanalytical method development and validation of entrectinib in rat plasma by liquid chromatography-tandem mass spectrometry. Asian J Pharm Clin Res. 2020;13(11):155-63. doi: 10.22159/ajpcr.2020.v13i11.39005

Tijare LK, Nt R, Un M. A review on bioanalytical method development and validation. Asian J Pharm Clin Res. 2016;9(9);Suppl 3:6-10. doi: 10.22159/ajpcr.2016.v9s3.14321.

Kirthi R, Shanmugam R, Prathyusha MS, Basha DJ. A review on bioanalytical method development and validation by RP-HPLC. J Glob Trends Pharm Sci. 2014;5(4):2265-71.

Goel D. Ticagrelor: the first approved reversible oral antiplatelet agent. Int J Appl Basic Med Res. 2013;3(1):19-21. doi: 10.4103/2229-516X.112234, PMID 23776835.

Nurden AT, Nurden P, Sanchez M, Andia I, Anitua E. Platelets and wound healing. Front Biosci. 2008;13(9):3532-48. doi: 10.2741/2947, PMID 18508453.

Hernandez Hernandez R, Carvajal AR, Guerrero Pajuelo J, Armas de Hernandez MJ, Armas Padilla MC, Barragan O, Boada Boada JJ, Roa E. The effect of doxazosin on platelet aggregation in normotensive subjects and patients with hypertension: an in vitro study. Am Heart J. 1991;121(1):389-94. doi: 10.1016/0002-8703(91)90877-K.

Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007;357(24):2482-94. doi: 10.1056/NEJMra071014, PMID 18077812.

Watson SP, Auger JM, McCarty OJ, Pearce AC. GPVI and integrin alphaIIb beta3 signaling in platelets. J Thromb Haemost. 2005;3(8):1752-62. doi: 10.1111/j.1538-7836.2005.01429.x, PMID 16102042.

Namrata K, Prashant P, Sunil A. Role of micronutrients in heart diseases. Int J Curr Pharm Res. 2021;13(5):1-5. doi: 10.22159/ijcpr.2021v13i5.1880

Epstein FH, Fuster V, Badimon L, Badimon JJ, Chesebro JH. The pathogenesis of coronary artery disease and the acute coronary syndromes. N Engl J Med. 1992;326(4):242-50. doi: 10.1056/NEJM199201233260406.

El Haouari M, Rosado JA. Medicinal plants with antiplatelet activity. Phytother Res. 2016;30(7):1059-71. doi: 10.1002/ptr.5619, PMID 27062716.

Rada FH. Antiplatelet adequacy of cyclopentyl triazolopyrimidine versus clopidogrel in-patients with coronary heart disease. Asian J Pharm Clin Res. 2018;11(12):536-9. doi: 10.22159/ajpcr.2018.v11i12.29703.

Mazyed EA, Zakaria S. Enhancement of dissolution characteristics of clopidogrel bisulphate by proniosomes. Int J Appl Pharm. 2019;11(2):77-85. doi: 10.22159/ijap.2019v11i2.30575.

Deshkar SS, Pawara AS, Shirolkar SV. Formulation and optimization of floating tablets of clopidogrel bisulfate using design of experiments. Int J Appl Pharm. 2018;10(6):94-102. doi: https://doi.org/10.22159/ijap.2018v10i6.27873

Shifrin MM, Widmar SB. Platelet inhibitors. Nurs Clin North Am. 2016;51(1):29-43. doi: 10.1016/j.cnur.2015.10.004, PMID 26897422.

Jain HK, Deore DD. Bioanalytical method development and validation for estimation of clopidogrel bisulfate in human plasma by RP-HPLC. Int J Appl Pharm. 2018;8(4):18-21. doi: https://doi.org/10.22159/ijap.2016v8i4.13521

Suhas G, Venkatamahesh R. Development and validation of a derivative UV-spectrophotometric method for quantitative estimation of clopidogrel bisulfate in bulk and pharmaceutical dosage form. Int J Chem Res. 2012;4:497-501.

Patil L, Gudi V, Jadhav D, Kadam Y, Dalvi D. Development and validation of a UV-spectrophotometric method for simultaneous estimation of amlodipine besylate and clopidogrel bisulfate in bulk and tablet dosage form. Scholars Res Library 2013;5:282-7.

Venkanna B, Shreedhara C, Ajitha M. Rapid and rugged bioanalytical method development and validation clopidogrel in human plasma using liquid chromatography/tandem mass spectroscopy. Am J PharmTech Res. 2011;1(2):66-80.

Harahap Y, Maysyarah I. Analytical validation of clopidogrel in human plasma through ultrahigh performance liquid chromatography-tandem mass spectrometry. Int J Appl Pharm. 2017;9;Suppl 1:163-7. doi: 10.22159/ijap.2017.v9s1.79_86.

Reddy BKK, Sekhar KBC, Mohan CK. Bioanalytical method development and validation for the simultaneous determination of vildagliptin and telmisartan in rabbit plasma using RP-HPLC. J Pharm Res Int. 2021;33(1):76-86. doi: 10.9734/jpri/2021/v33i131141.

Tijare LK, Nt R, Un M. A review on bioanalytical method development and validation. Asian J Pharm Clin Res. 2016;9(9);Suppl 3:6-10. doi: 10.22159/ajpcr.2016.v9s3.14321.

Sandhya P, Subrahmanyam CVS, Patnaik KR. Bioanalytical method development and validation of valsartan in rabbit plasma. Int J Pharm. 2015;5(4):1360-4.

Kumar SS, Muruganantham V. A simple and rugged bioanalytical method development and validation of Brivudine in human plasma by using high-performance liquid chromatography. Int J Pharm Pharm Sci. 2020;12(7):45-50. doi: https://doi.org/10.22159/ijpps.2020v12i7.37703

Venkatesh G, Majid MI, Ramanathan S, Mansor SM, Nair NK, Croft SL, Navaratnam V. Optimization and validation of RP-HPLC-UV method with solid-phase extraction for determination of Buparvaquone in human and rabbit plasma: application to pharmacokinetic study. Biomed Chromatogr. 2008;22(5):535-41. doi: 10.1002/bmc.965, PMID 18205140.

Kalshetti MS, Patil RY, Karale RA, Kulkarni AA. Bioanalytical method development for estimation of deferasirox in human plasma. Int J Pharm Pharm Sci. 2015;7(9):399-402.

Patel D, Sawant KK. Oral bioavailability enhancement of acyclovir by self-micro emulsifying drug delivery systems (SMEDDS). Drug Dev Ind Pharm. 2007;33(12):1318-26. doi: 10.1080/03639040701385527, PMID 18097805.

Madhavi S, Rani AP. Bioanalytical method development and validation for the determination of sofosbuvir from human plasma. Int J Pharm Pharm Sci. 2017;9(3):35-41. doi: 10.22159/ijpps.2017v9i3.16185.

Patel JM, Dhingani AP, Garala KC, Raval MK, Sheth NR. Development and validation of bioanalytical HPLC method for estimation of telmisartan in rat plasma: application to pharmacokinetic studies. Dhaka Univ J Pharm Sci. 2012;11(2):121-7. doi: 10.3329/dujps.v11i2.14562.

FDA guidance for industry: bioanalytical method validation. United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 2001.

Zhang Y, Huo M, Zhou J, Xie S. PK solver: an add-in program for pharmacokinetic and pharmacodynamic data analysis in microsoft excel. Comput Methods Programs Biomed. 2010;99(3):306-14. doi: 10.1016/j.cmpb.2010.01.007, PMID 20176408.

ICH Harmonized tripartite guideline validation of analytical procedures: text and methodology;Q2: (R1), Parent Guidelines; 1994.