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
Affiliations
Elizaveta N. Fisher
I.M. Sechenov First MSMU of the Ministry of Health of the Russian Federation, Sechenov University, 8, Trubetskaya Street, 119991 Moscow, Russia
Evgeny S. Melnikov
I.M. Sechenov First MSMU of the Ministry of Health of the Russian Federation, Sechenov University, 8, Trubetskaya Street, 119991 Moscow, Russia
Vladimir Gegeckori
I.M. Sechenov First MSMU of the Ministry of Health of the Russian Federation, Sechenov University, 8, Trubetskaya Street, 119991 Moscow, Russia
Natalya V. Potoldykova
Institute for Urology and Reproductive Health, I.M. Sechenov First MSMU of the Ministry of Health of the Russian Federation, Sechenov University, 8, Trubetskaya Street, 119991 Moscow, Russia
Dmitry V. Enikeev
Institute for Urology and Reproductive Health, I.M. Sechenov First MSMU of the Ministry of Health of the Russian Federation, Sechenov University, 8, Trubetskaya Street, 119991 Moscow, Russia
Kirill A. Pavlenko
Moscow Clinical Scientific Center, 86, Shosse Enthuziastov, 111123 Moscow, Russia
Snezana Agatonovic-Kustrin
I.M. Sechenov First MSMU of the Ministry of Health of the Russian Federation, Sechenov University, 8, Trubetskaya Street, 119991 Moscow, Russia
David W. Morton
I.M. Sechenov First MSMU of the Ministry of Health of the Russian Federation, Sechenov University, 8, Trubetskaya Street, 119991 Moscow, Russia
Galina V. Ramenskaya
I.M. Sechenov First MSMU of the Ministry of Health of the Russian Federation, Sechenov University, 8, Trubetskaya Street, 119991 Moscow, Russia
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.
