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Bioanalytical method development and validation of fenofibrate

Author Affiliations

  • 1Central Analytical Laboratory, Department of Pharmacy, BIPS, Laknepally, Warangal-Telangana, India
  • 2Central Analytical Laboratory, Department of Pharmacy, BIPS, Laknepally, Warangal-Telangana, India
  • 3Central Analytical Laboratory, Department of Pharmacy, BIPS, Laknepally, Warangal-Telangana, India
  • 4Central Analytical Laboratory, Department of Pharmacy, BIPS, Laknepally, Warangal-Telangana, India

Res. J. Recent Sci., Volume 8, Issue (2), Pages 1-5, April,2 (2019)

Abstract

A selective, rapid, sensitive and Simple HPLC method development and validation was performed for estimating amount of fenofibrate in plasma (human). Ethyl acetate is used for the extraction of drug. At 295nm in U.V. detector on 5µm intensil using 60:40 v/v 20 mm ammonium acetate buffers with initial pH, C18 column (4.6x250mmx5µm), ACN as MP at a flow rate of 1 micro liter/minute chromatographic peaks was separated. From plasma, chromatograms showing excellent resolution and no interference. R.T of Fenofibrate and Nevirapine (internal standard) were approximately 6.6±0.05 minutes, 5.2± 0.03 min respectively. Above 62% the average recovery from human plasma was determined. According to the concentration range of 0.3 to 20μg/milliliter with coefficient of correlation (r2) 0.9983 this method was linear.

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