Journal
BIOMEDICAL CHROMATOGRAPHY
Volume 30, Issue 9, Pages 1467-1475Publisher
WILEY
DOI: 10.1002/bmc.3707
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A selective, sensitive and rapid liquid chromatographic method with electrospray ionization tandem mass spectrometric detection has been developed and validated for simultaneous quantification of sacubitril and valsartan in rat plasma using telmisartan as internal standard (IS). The analytes were extracted by deprotenization of 50L of plasma sample using 200L of acetonitrile. In a short chromatographic run of 1.50min run time, separation was achieved on a Hypersil Gold C-18 column using a mobile phase composed of 0.1% formic acid in Milli-Q water-0.1% formic acid in acetonitrile in gradient elution mode. The quantification of target compounds was performed in a positive electrospray ionization mode and multiple reaction monitoring. Response was a linear function of concentration in the ranges of 0.5-20,000ng/mL for both analytes, with r(2)>0.9997. The intra- and inter-day precision and accuracy results were <15% and acceptable as per US Food and Drug Administration guidelines. Stability of compounds were established in a battery of stability studies, i.e. bench-top, autosampler and long-term storage stability as well as freeze-thaw cycles. The validated method can be used as a routine method to support pharmacokinetic studies. Copyright (c) 2016 John Wiley & Sons, Ltd.
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