Development and validation of the liquid chromatography-tandem mass spectrometry method for quantitative estimation of candesartan from human plasma


Author(s): Shailesh T. Prajapati, Pratik K. Patel, Marmik Patel, Vijendra B. Chauhan, and Chhaganbhai N. Patel

Introduction: A simple and sensitive liquid chromatography-tandem mass spectrometry method was developed and validated for estimation of candesartan in human plasma using the protein precipitation technique. Materials and Methods: The chromatographic separation was performed on reverse phase using a Betasil C8 (100 x 2.1 mm) 5-μm column, mobile phase of methanol:ammonium tri-floro acetate buffer with formic acid (60:40 v/v) and flow rate of 0.45 ml/min. The protonated analyte was quantitated in positive ionization by multiple reaction monitoring with a mass spectrometer. The mass transitions m/z 441.2 → 263.2 and 260.2 → 116.1 were used to measure candesartan by using propranolol as an internal standard. Results: The linearity of the developed method was achieved in the range of 1.2–1030 ng/ml (r2 ≥ 0.9996) for candesartan. Conclusion: The developed method is simple, rapid, accurate, cost-effective and specific; hence, it can be applied for routine analysis in pharmaceutical industries.