LC-MS/MS ASSAY FOR IRBESARTAN IN HUMAN PLASMA USING SOLID PHASE EXTRACTION TECHNIQUE: A PHARMACOKINETIC STUDY
Keywords:
Irbesartan, Nil, LC-MSMS, Method validation, PharmacokineticsAbstract
Objective: The objective of this research was to develop a novel liquid chromatography/tandem mass spectrometry (LC-MS/MS) method for the determination of irbesartan in human plasma.
Methods: An analytical method based on liquid chromatography/tandem mass spectrometry (LC-MS/MS) has been developed and validated for the quantitative determination of irbesartan in human plasma. The method utilizes irbesartan d4 as internal standard (IS). After solid phase extraction (SPE), analyte and the IS were chromato graphed on a C18 columns using a isocratic mobile phase composed of methanol–0.2% formic acid (85:15, v/v) pumped at a flow rate of 0.70 mL/min.
Results: Precision and accuracy of the method was determined using five analytical batches in the concentration range of 50.0–9982 ng/ml. All the validation experiments were carried out as per the US FDA guidelines and results met the acceptance criteria.
Conclusion: The proposed LC–MS/MS assay method is simple, rapid and enough sensitive for the determination of irbesartan in human plasma. A chromatographic run time set at 2.0 min, thus can analyze more than 300 samples in a day. Also, the proposed method was found to be applicable to clinical studies.
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