METHOD DEVELOPMENT AND VALIDATION OF CLOPIDOGREL DRUG IN THE DRUG SUBSTANCES AND DOSAGE FORM BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
Abstract
The present work describes a validated reverse phase high performance liquid chromatographic method for estimation of Clopidogrel in the drug substances and dosage form. The quantification was carried out using Ultron ES OVM (150*4.6) mm, 5µm and mobile phase comprised of Buffer, Acetonitrile and in proportion of 70:30 %v/v. The flow rate was 1.0 ml/min and the eluent was monitored at 220 nm. The selected chromatographic conditions were found to effectively quantitate Clopidogrel at retention time of about 3.8 min. Linearity were found to be in the range of 11-75 μg/ml. The percentage recoveries of all the drugs were found to be 99.3-101.1%. The proposed method was found to be fast, specific, accurate, precise, and reproducible and can be used for estimation of the Clopidogrel drugs.
Keywords: Clopidogrel, Reversed-phase HPLC.
DOI
https://doi.org/10.22270/jddt.v8i4.1756References
Ahuja S, Dong MW, (2005), Handbook of Pharmaceutical Analysis by HPLC, Elsevier/Academic Press
Saravanan V., Revathi R., Meera N. method development and validation for the simultaneous estimation of lycopene and ubidecarenone by RP-HPLC in combined pharmaceutical dosage form. Journal of Drug Delivery and Therapeutics, 2016; 6(5):46-51. doi:10.22270/jddt.v6i5.1295
Kazakevich YK, LoBrutto R, (2007), HPLC for Pharmaceutical Scientists, Wiley.
Bhowmick M., Bhowmick P., Sengodan T., Thangavel S. Development and validation of bioanalytical RP HPLC method for the estimation of metoprolol tartrate in rabbit plasma after transdermal and oral administration: application in pharmacokinetic studies. Journal of Drug Delivery and Therapeutics, 2015; 5(4):43-53. doi:10.22270/jddt.v5i4.1118
Lloyd R. Snyder and John W. Dolan (2008) A recent book provides a comprehensive treatment of the theory of high-performance gradient chromatography.
Snyder LR, Kirkland JJ, Dolan JW, (2009)Introduction to Modern Liquid Chromatography,
Dong MW, (2009) Modern HPLC for practicing scientists. Wiley
Savi P, Zachayus JL, Delesque-Touchard N et al. "The active metabolite of Clopidogrel disrupts P2Y12 receptor oligomers & partitions them out of lipid rafts". Proceedings of the National Academy of Sciences of the USA 2006; 103(29):11069-11074.
Pereillo JM, Maftouh M, Andrieu A, Uzabiaga MF, Fedeli O, Savi P, Pascal M, Herbert JM, Maffrand JP, Picard C. "Structure and stereochemistry of the active metabolite of clopidogrel". Drug Metab. Dispos. 2002; 30(11):1288–95.
Rossi S, editor. Australian Medicines Handbook 2006. Adelaide: Australian Medicines Handbook; 2006.
Michael D Randall; Karen E Neil (2004). Disease management. 2nd ed. London: Pharmaceutical Press. 159.
Chan FK, Ching JY, Hung LC, et al. "Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding". N. Engl. J. Med. 2005; 352(3):238–44.
John Wiley & Sons, New York, (1997) LC Method Development
Neue UD, (1997) HPLC Columns: Theory, Technology, and Practice, Wiley-VCH, New York
Published
Abstract Display: 530 
PDF Downloads: 900 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.