Development and validation of UPLC tandem mass spectrometry assay for separation of a phase II metabolite of ramipril using actual study samples and its application to a bioequivalence study.
In this paper, we present a validated UPLC-MS/MS assay for determination of ramipril and ramiprilat from human plasma samples. The assay is capable of isolating phase II metabolites (acylglucornides) of ramipril from in vivo study samples which is otherwise not possible using conventional HPLC conditions. Both analytes were extracted from human plasma using solid-phase extraction technique. Chromatographic separation of analytes and their respective internal standards was carried out using an Acquity UPLC BEH C(18) (2.1 × 100 mm), 1.7 µm column followed by mass spectrometric detection using an Waters Quattro Premier XE. The method was validated over the range 0.35-70.0 ng/mL for ramipril and 1.0-40.0 ng/mL for ramiprilat.
Pudage
Ashutosh
A
Department of Chemistry, Ramnarain Ruia College, Mumbai University, Matunga, India. ashutosh.pudage@accutestindia.com
Kamat
Sudhir
S
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D020719:Glucuronides; D006801:Humans; D017257:Ramipril / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D052616:Solid Phase Extraction; D021241:Spectrometry, Mass, Electrospray Ionization; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
D020719:Glucuronides; C052549:ramiprilat; D017257:Ramipril