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Quantification of granisetron in human plasma by liquid chromatography coupled to electrospray tandem mass spectrometry
Authors:Nirogi Ramakrishna V S  Kandikere Vishwottam N  Shukla Manoj  Mudigonda Koteshwara  Maurya Santosh  Boosi Ravikumar
Institution:Biopharmaceutical Research, Suven Life Sciences Ltd, Serene Chambers, Road 7, Banjara Hills, Hyderabad 500034, India. ramakrishna.nirogi@yahoo.co.in
Abstract:A simple, sensitive and rapid high-performance liquid chromatography/electrospray ionization tandem mass spectrometry method was developed and validated for the assay of granisetron in human plasma. Following liquid-liquid extraction, the analytes were separated using an isocratic mobile phase on a reversed-phase C18 column and analyzed by MS in the multiple reaction monitoring mode using the respective M+H]+ ions, m/z 313/138 for granisetron and m/z 409/228 for the IS. The assay exhibited a linear dynamic range of 0.1-20 ng/mL for granisetron in human plasma. The lower limit of quantification was 100 pg/mL with a relative standard deviation of less than 5%. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. A run time of 2.0 min for each sample made it possible to analyze more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies.
Keywords:granisetron  electrospray ionization  liquid chromatography–tandem mass spectrometry  pharmacokinetic study
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