BIOANALYTICAL METHOD DEVELOPMENT FOR ESTIMATION OF DEFERASIROX IN HUMAN PLASMA

  • M. S. Kalshetti Solapur University
  • R. Y. Patil Solapur University
  • R. A. Karale Department of Quality Assuarance, D. S. T. S. Mandal’s College of Pharmacy, Solapur University, Solapur, Maharashtra, India 413004
  • A. A. Kulkarni Solapur University

Abstract

Objective: A rapid and selective high performance liquid chromatography (HPLC) method for estimation of Deferasirox in Human plasma was developed and validated.

Methods: Analyte was recovered by protein precipitation technique and subsequently separated on C18 column (150x4.5 mm, 5µ) by using acetonitrile: phosphate buffer pH 3.0(60:40) as mobile phase at a flow rate of 1.0 ml/min at 248 nm.

Results: The calibration curve was linear over the concentration range 0.4-4.8 µg/ml in human plasma. Within-batch and between-batch precision were<15% (at LLOQ<20%) and accuracy was all within 15%. (at LLOQ<20%).

Conclusion: The developed and validated HPLC method was specific, sensitive and reproducible which can be used for routine drug analysis and bioanalysis.

 

Keywords: HPLC-UV, Bioanalytical, Deferasirox, Human plasma

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References

1. http://www.druglib.com/druginfo/exjade/description_pharmacology. [Last accessed on 05 Apr 2015].
2. The Merck Index. 14thed. Merck and Co., Inc., White house Station (USA); 2006. p. 483.
3. Martindale-The Complete Drug Reference. 35th edition. Pharmaceutical Press: London; 2005. p. 745.
4. Somisetty V, Bichala P. Development and validation of newer analytical methods for the estimation of deferasirox in bulk and in tablet dosage form by calorimetric method. Int J Pharm Pharm Sci 2013;5:521-5.
5. Chauzit, Emmanuelle, Bouchet. A method to measure deferasirox in plasma using HPLC coupled with ms/ms detection and its potential application. Ther Drug Monit 2010;32:476-81.
6. Manzoori J, Jouyban A, Amjadi M. Terbium-sensitized fluorescence method for the determination of deferasirox in biological fluids and tablet formulation. J Biolumin Chemilumin 2010;26:23-5.
7. Chakravarthy V, Gowrisankar D. LC determination of deferasirox in pharmaceutical formulation. J Global Trends Pharm Sci 2010;1:37-45.
8. Ravi K, Surendranath K, Radhakrishnanand P, Satish J, Satyanarayana P. A stability indicating LC method for deferasirox in bulk drugs and pharmaceutical dosage forms. Chromatographia 2010;72:441-6.
9. Sechaud R, Dutreix C, Balez S, Pommier F, Dumortier T, Morisson S, et al. Relative bioavailability of deferasirox tablets administered without dispersion and dispersed in various drinks. J Clin Pharmacol Ther 2008;46:102-8.
10. Bruin G, Faller T, Wiegand H, Schweitzer A, Nick H, Schneider J, et al. Pharmacokinetics, distribution, metabolism, and excretion of deferasirox and its iron complex in rats. Drug Metab Dispos 2008;36:23-5.
11. U. S. Department of Health and human services food and drug administration centre for drug evaluation and research (CDER) Centre for Veterinary Medicine (CVM), Guidance for Industry Bioanalytical Method Validation; 2001.
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How to Cite
Kalshetti, M. S., R. Y. Patil, R. A. Karale, and A. A. Kulkarni. “BIOANALYTICAL METHOD DEVELOPMENT FOR ESTIMATION OF DEFERASIROX IN HUMAN PLASMA”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 7, no. 9, July 2015, pp. 399-02, https://innovareacademics.in/journals/index.php/ijpps/article/view/6702.
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