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

Elizaveta N. Fisher; Evgeny S. Melnikov; Vladimir Gegeckori; Natalya V. Potoldykova; Dmitry V. Enikeev; Kirill A. Pavlenko; Snezana Agatonovic-Kustrin; David W. Morton; Galina V. Ramenskaya

doi:10.3390/molecules27227831

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

Elizaveta N. Fisher^*, Evgeny S. Melnikov, Vladimir Gegeckori, Natalya V. Potoldykova, Dmitry V. Enikeev, Kirill A. Pavlenko, Snezana Agatonovic-Kustrin^*, David W. Morton, Galina V. Ramenskaya

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

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% v/v formic acid (aqueous solution) and 0.1% v/v 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.

Original language	English
Article number	7831
Journal	Molecules
Volume	27
Issue number	22
DOIs	https://doi.org/10.3390/molecules27227831
State	Published - Nov 2022
Externally published	Yes

Keywords

GnRH analogs
LC-ESI-MS/MS
peptide drugs
solid-phase extraction
somatostatin analogue

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10.3390/molecules27227831

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Fisher, E. N., Melnikov, E. S., Gegeckori, V., Potoldykova, N. V., Enikeev, D. V., Pavlenko, K. A., Agatonovic-Kustrin, S., Morton, D. W., & Ramenskaya, G. V. (2022). Development and Validation of an LC-MS/MS Method for Simultaneous Determination of Short Peptide-Based Drugs in Human Blood Plasma. Molecules, 27(22), Article 7831. https://doi.org/10.3390/molecules27227831

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

abstract = "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% v/v formic acid (aqueous solution) and 0.1% v/v 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.",

keywords = "GnRH analogs, LC-ESI-MS/MS, peptide drugs, solid-phase extraction, somatostatin analogue",

author = "Fisher, {Elizaveta N.} and Melnikov, {Evgeny S.} and Vladimir Gegeckori and Potoldykova, {Natalya V.} and Enikeev, {Dmitry V.} and Pavlenko, {Kirill A.} and Snezana Agatonovic-Kustrin and Morton, {David W.} and Ramenskaya, {Galina V.}",

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year = "2022",

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doi = "10.3390/molecules27227831",

language = "אנגלית",

volume = "27",

journal = "Molecules",

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AU - Fisher, Elizaveta N.

AU - Melnikov, Evgeny S.

AU - Gegeckori, Vladimir

AU - Potoldykova, Natalya V.

AU - Enikeev, Dmitry V.

AU - Pavlenko, Kirill A.

AU - Agatonovic-Kustrin, Snezana

AU - Morton, David W.

AU - Ramenskaya, Galina V.

PY - 2022/11

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N2 - 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% v/v formic acid (aqueous solution) and 0.1% v/v 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.

AB - 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% v/v formic acid (aqueous solution) and 0.1% v/v 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.

KW - GnRH analogs

KW - LC-ESI-MS/MS

KW - peptide drugs

KW - solid-phase extraction

KW - somatostatin analogue

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

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