Development and validation of HPLC method for simultaneous determination of Gliclazide and Enalapril maleate in tablet dosage form

  • Md Abdullah Al Mahmud Department of Pharmacy, Primeasia University, 12 Kemal Ataturk Avenue, Banani, Dhaka-1213
  • Subrata Bhadra Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000
  • Afroza Haque Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000
  • Md Elias Al Mamun Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000
  • Syed Shabbir Haider Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000
Keywords: Gliclazide, enalapril maleate, HPLC, method development, validation

Abstract

This paper describes a simple, sensitive and selective high performance liquid chromatographic (HPLC) method for the separation and determination of gliclazide (GLI) and enalapril (ENA) maleate simultaneously in tablet dosage forms. The chromatographic separation was performed on an ODS column (250 mm × 4.6 mm i.d., 5 ?m particle size) at 40 ± 0.5°C, with a mobile phase composed of phosphate buffer (pH 4.4), acetonitrile and methanol in the ratio of 45:40:15, (v/v/v). The flow rate was maintained at 1.5 ml/min, injected volume was 20 ?l and detection wavelength was 217 nm. The method was validated according to ICH Q2 (R1) guidelines and found to be linear over a range of 40-120 ?g/ml (R2 = 0.991) and 2.5-7.5 ?g/ml (R2 = 0.998) for gliclazide and enalapril maleate, respectively. The proposed method was applied successfully for the assay of these two drugs in their combined inhouse developed tablet formulations and could be applicable for routine quality control analysis.

DOI: http://dx.doi.org/10.3329/dujps.v13i1.21859

Dhaka Univ. J. Pharm. Sci. 13(1): 51-56, 2014 (June)

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Abstract
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Published
2015-02-03
How to Cite
Al Mahmud, M. A., Bhadra, S., Haque, A., Al Mamun, M. E., & Haider, S. (2015). Development and validation of HPLC method for simultaneous determination of Gliclazide and Enalapril maleate in tablet dosage form. Dhaka University Journal of Pharmaceutical Sciences, 13(1), 51-56. https://doi.org/10.3329/dujps.v13i1.21859
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