Method development and validation of aspirin and clopidogrel pharmaceutical dosage forms by developing new RP HPLC method

Authors

  • Nellore Dharani Sai Sreekanth Sree Dattha Institute of Pharmacy
  • Nenavath Adilakshmi Bojjam Narsimhulu Pharmacy College for Women.

DOI:

https://doi.org/10.18231/j.joapr.2020.v.8.i.3.38.47

Keywords:

Dosage forms, UV Spectroscopy, Solubility, High Performance Liquid Chromatography, Validation parameters

Abstract

A simple and selective LC method is described for the determination of Aspirin and Clopidogrel in tablet dosage forms. Chromatographic separation was achieved on a c18 column along with mobile phase consisting of a combination of fifty five volumes of Mixed Phosphate Buffer and forty five volumes of Acetonitrile with detection of 235 nm. Linearity was observed in the range 20-60 μg/ml for Aspirin (r2=0.998) and 10-30 μg /ml for Clopidogrel (r2 =0.998) for the amount of drugs estimated by the projected ways was in smart agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD trials. All statistical data proves validity of the ways and may be used for routine analysis of pharmaceutical dosage form.

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References

Tzanavaras PD, Themelis DG. Review of recent applications of flow injection spectrophotometry to pharmaceutical analysis. Analytica Chimica Acta, 588, 1–9 (2007).

Wermuth CG. Analogues as a Means of Discovering New Drugs. Analogue-based Drug Discovery. Wiley-VCH Verlag GmbH & Co. KGaA, pp.1–23 (2006).

Hamilton RJ. Tarascon pocket Pharmacopoeia 2016: lab-coat edition. Jones & Bartlett Learning, pp. 5 (2015)

Brayfield A. Aspirin. Martindale: The Complete Drug Reference. Pharmaceutical Press, London, (2014).

Aspirin, https://www.drugs.com/monograph/aspirin.html, cited 29 November, 2019

Aspirin (Rx, OTC), https://reference.medscape.com/drug/bayer-ecotrin-aspirin-343279#showall, cited 29 November, 2019

Jeffreys D. Aspirin: the remarkable story of a wonder drug. Bloomsbury, London (2005)

Clopidogrel Pregnancy and Breastfeeding Warnings, https://www.drugs.com/pregnancy/clopidogrel.html, cited 30 November 2019

Clopidogrel Bisulfate, https://www.drugs.com/monograph/clopidogrel-bisulfate.html, cited 30 November 2019

Kumar A, Kishore L, Kaur N, Nair A. Method development and validation: Skills and tricks. Chronicles of Young Scientists, 3(1), 3 (2012).

Chatrabhuji PM, Pandya C V, Patel MC. Development and validation of RP-HPLC-UV method for simultaneous quantitation of clopidogrel bisulphate and aspirin in bulk drug. Anal. Chem. an indian J., 15, 69–76 (2015).

Sundar RS, Valliappan K. An improved RP-HPLC method for the simultaneous estimation of aspirin, Atorvastatin, And clopidogrel in pharmaceutical formulation using experimental design methodology. Int. J. Pharm. Pharm. Sci., 6, 279–83 (2014).

Sultana N, Ali KA, Arayne MS, Nawaz M. Simultaneous Determination of Clopidogrel and Aspirin by RP-HPLC from Bulk Material and Dosage Formulations Using Multivariate Calibration Technique. Journal of Chromatographic Science, 49, 165–9 (2011).

Shrivastava P, Basniwal P, Jain D, Shrivastava S. Concurrent estimation of clopidogrel bisulfate and aspirin in tablets by validated RP-HPLC method. Indian J Pharm Sci, 70, 667 (2008).

Gousuddin M, Sengupta P, Datt Tripathi V, Das A. Stability Indicating RP-HPLC Method for Simultaneous Determination of Aspirin and Clopidogrel in Dosage Form. Malaysian J. Anal. Sci., 20, 247–57 (2016).

Sinha PK, Damle MC, Bothara KG. A Validated Stability Indicating HPTLC method for determination of aspirin and clopidogrel bisulphate in combined dosage form. Eurasian J. Anal. Chem. 4(2), 152-160, (2009)

Published

2020-08-31

How to Cite

Dharani Sai Sreekanth, N., & Adilakshmi, N. . (2020). Method development and validation of aspirin and clopidogrel pharmaceutical dosage forms by developing new RP HPLC method. Journal of Applied Pharmaceutical Research, 8(3), 38-47. https://doi.org/10.18231/j.joapr.2020.v.8.i.3.38.47

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Articles