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) Vol. 27; no. 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:	Journal Article
Language:	English
Published:	Switzerland MDPI AG 01-11-2022 MDPI
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 Japan Russia peptide drugs somatostatin analogue solid-phase extraction GnRH analogs LC-ESI-MS/MS
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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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1420-3049 1420-3049
DOI:	10.3390/molecules27227831