title: Analysis of prasugrel active metabolite R-138727 in human plasma: a sensitive, highly selective and fast LC-MS/MS method.
abstract: A cost effective, sensitive, simple, and rapid high-performance liquid chromatography-tandem mass spectrometry method was developed and validated for the quantification of the prasugrel metabolite in human plasma. Following solid phase extraction, the analyte (prasugrel active metabolite; R-138727) and internal standard (emtricitabine) were separated using a mobile phase in an isocratic elution mode on a reverse phase C18 column and were analyzed by an LC-MS/MS in the multiple reaction monitoring mode using the respective [M+H](+) ions, m/z 498.3-206.0 for R-138727 and m/z 248.2-130.1 for the internal standard. The assay exhibited a linear dynamic range of 0.2-120 ng/mL. The lower limit of quantification was 0.2 ng/mL with a relative standard deviation of 5.0%. This LC-MS/MS method was validated with intra-batch and inter-batch precision and accuracy. Results for precision and accuracy are in range of 3.9-9.6% and 95.2-102.2% respectively. This validated method is simple and repeatable to use in bioequivalence/pharmacokinetic studies.
authors.affiliation: Department of Pharmacy, Acharya Nagarjuna University, Guntur, India. Electronic address: kakarla14@gmail.com.
authors.forename: Sreekanth
authors.initials: S
authors.lastname: Kakarla
authors.affiliation: Clinical research and biosciences division (CRBio), Hyderabad, India.
authors.forename: Peda Varma
authors.initials: PV
authors.lastname: Datla
authors.affiliation: Department of Pharmacognosy and Phytochemistry, Shadan Women's College of Pharmacy, Hyderabad, India.
authors.forename: Geetha
authors.initials: G
authors.lastname: Kodali
authors.affiliation: Gitam Institute of Pharmacy, Gitam University, Visakhapatnam, India.
authors.forename: Ganapaty
authors.initials: G
authors.lastname: Seru
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D006801:Humans; D016014:Linear Models; D010879:Piperazines / Q000097:blood*; D000068799:Prasugrel Hydrochloride / Q000097:blood*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D010879:Piperazines; C510685:R-138727; D000068799:Prasugrel Hydrochloride
keywords: Human plasma; Liquid chromatography-tandem mass spectrometry; Prasugrel metabolite (R-138727)