title: High-throughput quantification of perindopril in human plasma by liquid chromatography/tandem mass spectrometry: application to a bioequivalence study.
abstract: A simple, sensitive and rapid high-performance liquid chromatography/positive ion electrospray tandem mass spectrometry method was developed and validated for the quantification of perindopril in human plasma. Following liquid-liquid extraction, the analytes were separated using an isocratic mobile phase on a reversed-phase column and analyzed by mass spectrometry in the multiple reaction monitoring mode using the respective [M+H](+) ions, m/z 369/172 for perindopril and m/z 417/234 for the internal standard. The method exhibited a linear dynamic range of 0.1-100 ng/mL for perindopril in human plasma. The lower limit of quantification was 0.1 ng/mL with a relative standard deviation of less than 6.1%. 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 450 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability and bioequivalence studies.
authors.affiliation: Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Road #7, Banjara Hills, Hyderabad 500 034, India.
authors.forename: Ramakrishna V S
authors.initials: RV
authors.lastname: Nirogi
authors.forename: Vishwottam N
authors.initials: VN
authors.lastname: Kandikere
authors.forename: Manoj
authors.initials: M
authors.lastname: Shukla
authors.forename: Koteshwara
authors.initials: K
authors.lastname: Mudigonda
authors.forename: Santosh
authors.initials: S
authors.lastname: Maurya
authors.forename: Prashanth
authors.initials: P
authors.lastname: Komarneni
mesh_terms: D000806:Angiotensin-Converting Enzyme Inhibitors / Q000097:blood* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D015394:Molecular Structure; D020913:Perindopril / Q000097:blood* / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D020913:Perindopril