A Sensitive Method for Determination of Residual EDTA in Diuretic Drugs, Furosemide by Reversed Phase High Performance Liquid Chromatography

Authors

  • Rohidas Gilbile  Department of Chemistry, Pacific Academy of Higher Education and Research University, Udaipur, Rajasthan, India
  • Dr. Saleem Shaikh  Ullmann Laboratories, Five Star Shendra ,MIDC Aurangabad, Maharashtra State, India.
  • Dr. Ritu Vyas  

Keywords:

A sensitive method for determination of residual EDTA in diuretic drugs, furosemide by reversed phase high performance liquid chromatography

Abstract

A sensitive method for the determination of residual EDTA by high-performance liquid chromatographic method with UV detection has been developed. The analysis was performed in gradient mode on a reversed phase C18 column, 150 mm x 4.6 mm x 5 m. Gradient mobile phase consisted of a 25mM tetrabutyl ammonium hydrogen sulphate, in water as mobile phase A and acetonitrile as mobile phase B. The linear gradient conditions 0-7 minutes 2%B; 7-10 minutes 80%B; 10-15 minutes 80%B, 15-17 minutes 2%B and 17-32 minutes2%B was set for the determination of residual EDTA . Chromatograms were recorded by using flow rate 1.0 mL/minute and the injection volume was 25 µL. The detection wavelength was set at 258 nm. The proposed liquid chromatographic method was successfully applied to the determination of residual EDTA in furosemide. A linear calibration graph was obtained for 25% to 150%of specification limit (200 ppm) with a correlation coefficient of 0.9999 for EDTA. The quantification limit for EDTA in furosemide drug substances was found to be 50 ppm. The recovery for EDTA was found to be within the acceptance criteria (75-125%) from QL level to 150% of the specification limit. Limit of quantitation was found to be 50ppm. The precision of the method at 100% level for EDTA was within the acceptance criteria. The method developed in this study is sensitive and selective and can be applied to routine quality control

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International Journal of Scientific Research in Science, Engineering and Technology

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Published

2017-12-31

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Volume 3, Issue 8, November-December-2017

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Research Articles

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[1]
Rohidas Gilbile, Dr. Saleem Shaikh, Dr. Ritu Vyas, " A Sensitive Method for Determination of Residual EDTA in Diuretic Drugs, Furosemide by Reversed Phase High Performance Liquid Chromatography, International Journal of Scientific Research in Science, Engineering and Technology(IJSRSET), Print ISSN : 2395-1990, Online ISSN : 2394-4099, Volume 3, Issue 8, pp.720-727, November-December-2017.