Development and Validation of an LC-MS/MS Method for Simultaneous Determination of Short Peptide-Based Drugs in Human Blood Plasma

A novel HPLC-ESI-MS/MS method for simultaneous gonadotropin-releasing hormone (GnRH) analogs and somatostatin analog quantitation was developed and validated. The developed method was successfully applied to pharmacokinetic studies. The sample preparation process included solid-phase extraction (SPE...

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Bibliographic Details
Published in:Molecules (Basel, Switzerland) Switzerland), 2022-11, Vol.27 (22), p.7831
Main Authors: Fisher, Elizaveta N, Melnikov, Evgeny S, Gegeckori, Vladimir, Potoldykova, Natalya V, Enikeev, Dmitry V, Pavlenko, Kirill A, Agatonovic-Kustrin, Snezana, Morton, David W, Ramenskaya, Galina V
Format: Article
Language:English
Subjects:
Accuracy
Acetonitrile
Analysis
Aqueous solutions
Blood plasma
Cancer therapies
Chromatography
Chromatography, Liquid - methods
Correlation coefficient
Correlation coefficients
Drugs
Formic acid
GnRH analogs
Gonadotropin-releasing hormone
Gonadotropins
High performance liquid chromatography
Humans
LC-ESI-MS/MS
Liquid chromatography
Methods
Octreotide
Organic acids
Patients
peptide drugs
Peptides
Pharmacokinetics
Pituitary (anterior)
Pituitary hormones
Plasma
Prostate
Proteins
Quantitation
Reproducibility of Results
Sample preparation
Solid phases
solid-phase extraction
Somatostatin
somatostatin analogue
Tandem Mass Spectrometry - methods
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Summary:A novel HPLC-ESI-MS/MS method for simultaneous gonadotropin-releasing hormone (GnRH) analogs and somatostatin analog quantitation was developed and validated. The developed method was successfully applied to pharmacokinetic studies. The sample preparation process included solid-phase extraction (SPE). Effective chromatographic separation of the analytes and internal standard (dalargin) was achieved with a C18 column, using a gradient elution with two mobile phases: 0.1% / formic acid (aqueous solution) and 0.1% / formic acid (acetonitrile solution). The linearity of the method was demonstrated within a concentration range of 0.5-20 ng/mL, with correlation coefficients between 0.998-0.999 for goserelin, buserelin, triptorelin, and octreotide, respectively. The relative standard deviation (RSD, %) values for method accuracy and precision did not exceed 20% at the lower level of quantitation (LLOQ) or 15% at other concentration levels.
ISSN:1420-3049
1420-3049
DOI:10.3390/molecules27227831