A Validated High-Performance Liquid Chromatography-Tandem Mass Spectrometric (Lc-MsMs) Method for Simultaneous Determination of R(+)-Ketorolac and S(−)-Ketorolac in Human Plasma and Its Application to a Bioequivalence Study
Joint Authors
Patni, Anil K.
Iyer, Sunil S.
Jain, Rakesh
Rana, Sachin
Patri, Sabyasachi
Kumar, Sudershan
Monif, Tausif
Khuroo, Arshad H.
Source
Chromatography Research International
Issue
Vol. 2011, Issue 2011 (31 Dec. 2011), pp.1-11, 11 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2010-11-30
Country of Publication
Egypt
No. of Pages
11
Main Subjects
Abstract EN
We report a selective, accurate, and reproducible liquid chromatography-tandem mass spectrometric (LC-MS/MS) method that employs solid phase extraction for quantification of ketorolac enantiomers in human plasma.
Resolution of R(+)-ketorolac and S(−)-ketorolac was achieved using a Chiral-AGP column and a mobile phase of ammonium formate buffer (10 mM, pH 4.70±0.05):acetonitrile (85 : 15, v/v and 70 : 30, v/v) in a gradient time program.
S(+)-etodolac was used as the internal standard (IS).
Quantification was achieved using a positive electrospray ionization (ESI+) interface under multiple reaction monitoring (MRM) condition.
The method was validated over the concentration range of 9.36–1198.69 ng/ml for R(+)-ketorolac and 6.07–776.74 ng/ml for S(−)-ketorolac.
Matrix effect was found negligible and the method showed good performances in terms of accuracy (89.6–102.7%) and precision (1.7–6.7%) for both enantiomers.
Extraction recoveries of R(+)-ketorolac, S(−)-ketorolac, and S(+)-etodolac were 82.04, 70.94, and 93.90%, respectively.
Results of all stability exercises in human plasma were within acceptable limits.
The method was successfully applied to a single dose cross over bioequivalence study in healthy human male volunteers.
Incurred Sample Reanalysis (ISR) was performed by randomly selecting 10% of total subject samples of the study using Statistical Analysis Software (SAS).
Values of 91.1% for R (+)-ketorolac and 83.5% for S(−)-ketorolac indicated good acceptance for ISR.
American Psychological Association (APA)
Patri, Sabyasachi& Patni, Anil K.& Iyer, Sunil S.& Khuroo, Arshad H.& Monif, Tausif& Rana, Sachin…[et al.]. 2010. A Validated High-Performance Liquid Chromatography-Tandem Mass Spectrometric (Lc-MsMs) Method for Simultaneous Determination of R(+)-Ketorolac and S(−)-Ketorolac in Human Plasma and Its Application to a Bioequivalence Study. Chromatography Research International،Vol. 2011, no. 2011, pp.1-11.
https://search.emarefa.net/detail/BIM-455150
Modern Language Association (MLA)
Patri, Sabyasachi…[et al.]. A Validated High-Performance Liquid Chromatography-Tandem Mass Spectrometric (Lc-MsMs) Method for Simultaneous Determination of R(+)-Ketorolac and S(−)-Ketorolac in Human Plasma and Its Application to a Bioequivalence Study. Chromatography Research International No. 2011 (2011), pp.1-11.
https://search.emarefa.net/detail/BIM-455150
American Medical Association (AMA)
Patri, Sabyasachi& Patni, Anil K.& Iyer, Sunil S.& Khuroo, Arshad H.& Monif, Tausif& Rana, Sachin…[et al.]. A Validated High-Performance Liquid Chromatography-Tandem Mass Spectrometric (Lc-MsMs) Method for Simultaneous Determination of R(+)-Ketorolac and S(−)-Ketorolac in Human Plasma and Its Application to a Bioequivalence Study. Chromatography Research International. 2010. Vol. 2011, no. 2011, pp.1-11.
https://search.emarefa.net/detail/BIM-455150
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-455150