title: Quantitative determination of imatinib stability under various stress conditions.
abstract: OBJECTIVE
  A simple, rapid, reverse phase and stability-indicating high-performance liquid chromatography (HPLC) method for the estimation of imatinib in solution and in plasma under forced degradation conditions was developed.
  
  
  METHODS
  The method employed isocratic elution using a Waters Atlantis C18 (5 μ, 4.6 mm × 150 mm) HPLC column. The mobile phase consisted of acetonitrile and 10 mM KH2PO4 buffer in the ratio of 35:65 (v/v, pH = 4.6), which was delivered using isocratic flow at a rate of 1 mL/min. The injection volume of 50 μL and imatinib was monitored using UV detection 270 nm after a clean-up step with diethyl ether and with a total run time of 6 min.
  
  
  RESULTS
  The method was validated in solution as well as in plasma, and the response was found to be linear in the concentration range of 0.5-20 μg/mL. The coefficient of correlation was found to be >0.99. Forced degradation studies revealed that imatinib undergoes degradation under different stress conditions.
  
  
  CONCLUSIONS
  The developed HPLC method could effectively resolve degradation product peaks from imatinib except at neutral pH. Further, no interference was found at the retention time of imatinib from any plasma components, indicating selectivity of the developed method. The limits of detection and quantitation of the method were 0.025 and 0.5 μg/mL, respectively.
authors.affiliation: Department of Clinical Pharmacy, Pharmacokinetic Research Laboratory, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
authors.forename: Khalid Mohammed
authors.initials: KM
authors.lastname: Alkharfy
authors.forename: Rao Muzaffer Ali
authors.initials: RM
authors.lastname: Khan
authors.forename: Majed
authors.initials: M
authors.lastname: Al-Asmari
authors.forename: Baderelddin Hashim
authors.initials: BH
authors.lastname: Alhadeyah
authors.forename: Ajaz
authors.initials: A
authors.lastname: Ahmad
keywords: HPLC; imatinib; method validation; stability indicating
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