Enantioselective determination of R ‐(−)‐manidipine and S ‐(+)‐manidipine in human plasma by a sensitive and selective chiral LC–MS/MS assay

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EarlyView Article

  • Published: Jul 25, 2017
  • Author: Vinayender Adireddy, Bhavani Prasanna Kumar Bimireddy, Venkateswarlu Ponneri
  • Journal: Biomedical Chromatography

Abstract

A sensitive and selective liquid chromatography–tandem mass spectrometric (LC–MS/MS) assay method has been developed and validated for the enantioselective determination of manidipine in human plasma using isotope‐labeled compounds as internal standards. After solid‐phase extraction, R‐(−)‐manidipine and S‐(+)‐manidipine were chromatographed on a Chiralpack IC‐3 C18 column using a isocratic mobile phase composed of 2 mm ammonium bicarbonate and acetonitrile (15:85, v/v). The precursor ion to product ion transitions for the enantiomers and internal standards were monitored in the multiple reaction monitoring and positive ionization mode using an API‐4000 mass spectrometer. The method was linear over the concentration range of 0.05–10.2 ng/mL for both enantiomers. The precision and accuracy results over five concentration levels in five different batches were well within the acceptance limits. The mean extraction recovery was >80% for both enantiomers. A variety of stability tests were executed in plasma and in neat samples, which complies with the FDA guidelines. After complete validation, the method was successfully applied to a pharmacokinetic study of a manidipine 20 mg oral dose in 10 healthy South India subjects under fasting conditions. The assay reproducibility is shown through incurred samples reanalysis of 20 subject plasma samples.

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