DEVELOPMENT AND VALIDATION OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHYMETHOD FOR SIMULTANIOUS ESTIMATION OF AMLODIPINE BESYLATE AND IRBESARTAN IN SYNTHETIC MIXTURE

Authors

  • PATEL SEJAL K., Department of Pharmaceutical Quality Assurance, Shree S. K. Patel College of Pharmaceutical Education & Research, Ganpat University, Kherva – 382711, Mehsana, Gujarat, India.
  • DARJI MAUSAM S Department of Pharmaceutical Quality Assurance, Shree S. K. Patel College of Pharmaceutical Education & Research, Ganpat University, Kherva – 382711, Mehsana, Gujarat, India.

Keywords:

Amlodipine besylate, Irbesartan, RP-HPLC,Synthetic mixture, Method validation

Abstract

This research manuscript describes simple, sensitive, accurate, precise and repeatable reverse phase high performance
liquid chromatography method for the simultaneous determination of Amlodipine besylate(AMLO) and Irbesartan(IRBE) in synthetic mixture. The sample was analyzed by reverse phase C18 column (Phenomenex C18, 250 mm × 4.6 mm, 5?) as stationary phase; acetonitrile : methanol : water, pH 3.0 (25 : 20 : 55 , v/v/v) as a mobile phase at a flow rate of 1.0 ml/min. Quantification was achieved with Photo Diode Array detector at 238 nm. The retention time for Amlodipine besylate was found to be 3.6 min and for Irbesartan was found to be 6.3min. The linearity was obtained in the concentration range of 0.3-1.1 ?g/ml and 1-6?g/ml for AMLO and IRBE respectively. The method was successfully applied to synthetic mixture because no chromatographic interferences from formulation excipients were found. The method retained its accuracy and precision when the standard addition technique was applied.

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Published

2014-02-21
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PATEL SEJAL K., and DARJI MAUSAM S. “DEVELOPMENT AND VALIDATION OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHYMETHOD FOR SIMULTANIOUS ESTIMATION OF AMLODIPINE BESYLATE AND IRBESARTAN IN SYNTHETIC MIXTURE”. International Journal of Pharmaceutics and Drug Analysis, vol. 2, no. 2, Feb. 2014, pp. 94-99, https://ijpda.com/index.php/journal/article/view/22.

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