Персона: Шохин, Игорь Евгеньевич
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Инженерно-физический институт биомедицины
Цель ИФИБ и стратегия развития – это подготовка высококвалифицированных кадров на базе передовых исследований и разработок новых перспективных методов и материалов в области инженерно-физической биомедицины. Занятие лидерских позиций в биомедицинских технологиях XXI века и внедрение их в образовательный процесс, что отвечает решению практикоориентированной задачи мирового уровня – диагностике и терапии на клеточном уровне социально-значимых заболеваний человека.
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Игорь Евгеньевич
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- ПубликацияТолько метаданныеSimultaneous Determination of Candesartan and Hydrochlorothiazide in Human Plasma by HPLC-MS/MS(2021) Karnakova, P. K.; Archakova, O. A.; Shchelgacheva, D. S.; Aleshina, A. A.; Komarov, T. N.; Shohin, I. E.; Шохин, Игорь Евгеньевич© 2021, Center of Pharmaceutical Analytics. All rights reserved.Introduction. Combined drugs have the greatest efficacy and safety in arterial hypertension treatment. The combination of candesartan and hydrochlorothiazide (AT1-receptor antagonist and a thiazide diuretic, respectively) provides high efficiency of antihypertensive combination therapy, therefore it is widely used in medical practice. Developing a method for simultaneous determination of candesartan and hydrochlorithiazide in human blood plasma is necessary for performing the analytical part of pharmacokinetic studies and bioequivalence studies of multicomponent drugs. Aim. The aim of this study is to develop a method for quantitative determination of candesartan and hydrochlorothiazide in human plasma by high-performance liquid chromatography – tandem mass spectrometry (HPLC-MS/MS) for further bioequivalence studies. Materials and methods. Determination of candesartan and hydrochlorothiazide in human plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation. Internal standard: mixed solution of valsartan and indapamide. Mobile phase: 0.1 % formic acid solution in water (eluent A), 0.1 % formic acid in acetonitrile (eluent B). Column: Phenomenex Luna Phenyl-Hexyl, 50x4.6 mm, 5 μm. Analytical range: 2.00– 300.00 ng/mL for candesartan, 2.00–200.00 ng/mL for hydrochlorothiazide in human plasma. Ionization source: electrospray ionization. Detection conditions: 441.10 → 192.00 m/z, 441.10 → 263.15 m/z (candesartan), 295.85 → 269.00 m/z (hydrochlorothiazide), 436.00 → 207.05 m/z (valsartan), 363.85 → 132.10, 363.85 → 189.00 m/z (indapamide). Results and discussion. This method was validated by selectivity, matrix effect, calibration curve, accuracy, precision, spike recovery, the lower limit of quantification, carry-over effect and stability. The developed method meets the requirements for conducting bioequivalence studies of medicinal products within the framework of the Eurasian Economic Union. Conclusion. The analytical range was 2.00–300.00 ng/mL for candesartan, 2.00–200.00 ng/mL for hydrochlorothiazide in human plasma. The method was applied in BE study of the combination of candesartan and hydrochlorothiazide.
- ПубликацияТолько метаданныеPharmacokinetics Study of the Long-acting Antiarrhythmic Drug of Lappaconitine Hydrobromide (Allaforte®, JSC "Pharmcenter VILAR", Russia)(2022) Archakova, O. A.; Bagaeva, N. S.; Rogov, A. V.; Shchelgacheva, D. S.; Komarov, T. N.; Shohin, I. E.; Шохин, Игорь Евгеньевич© Archakova O. A., Bagaeva N. S., Komarov T. N., Rogov A. V., Shchelgacheva D. S., Suvorova A. V., Karnakova P. K., Karpova P. A., Shohin I. E., 2022.Introduction. Allaforte® (JSC "Pharmcenter VILAR", Russia) is an antiarrhythmic long-acting drug. The dosage form of the drug Allaforte® provides a decrease in the frequency of taking the drug and also reduces the risk of side effects. It is relevant when taking antiarrhythmic drugs of the IC class. However, the pharmacokinetics of this drug has not been studied on humans. Therefore, it is important to fully study the pharmacokinetics to ensure the maximum efficacy and safety of arrhythmia therapy. Aim. The aim is pharmacokinetics study of long-acting antiarrhythmic drug Allaforte® (JSC "Pharmcenter VILAR", Russia), 25 mg. Materials and methods. Concentration of lappaconitine and its active metabolite N-desacetyllappaconitine in human plasma determinates by high performance liquid chromatography with tandem mass-spectrometry. Pharmacokinetic parameters calculated by R Project 3.5.1 software (package «bear», version 2.8.3-2), originally created by Hsin-ya Lee and Yung-jin Lee, Taiwan. Results and discussion. Pharmacokinetic parameters of lappaconitine and N-desacetyllappaconitine were calculated. Averaged pharmacokinetic profiles (in linear and semi-log scale) of lappaconitine and N-desacetyllappaconitine after single administration under fasting were built. The means of the maximum concentrations (Cmax ) determined in the blood plasma of volunteers after single administration Allaforte® are 5.09 ± 4.07 ng/ml for lappaconitine and 11.66 ± 6.21 ng/ml for N-deacetyllappaconitine (Mean ± SD). The peak time of the maximum concentrations (Tmax ) is 4.43 ± 3.54 hours for lappaconitine and 4.04 ± 2.18 hours for N-deacetyllappaconitine. The means of the areas under the curve plasma concentration – time from 0 to 48 hours (AUC0-t ) and under the curve plasma concentration–time from zero to infinity (AUC0-∞ ) of Allaforte® is 42.96 ± 34.48 ng ∙ h/ml and 71.24 ± 43.20 ng ∙ h/ml for lappaconitine; 167.42 ± 114.41 ng ∙ h/ml and 189.42 ± 115.20 ng ∙ h/ml for N-deacetyllappaconitine. Allaforte® was eliminated from blood plasma with means of terminal half-life (T1/2 ) 8.45 ± 5.10 hours for lappaconitine and 9.04 ± 2.57 hours for N-deacetyllappaconitine. Conclusion. Pharmacokinetics study of long-acting antiarrhythmic drug Allaforte® (JSC "Pharmcenter VILAR", Russia) after single administration was researched. Results of the study allows to conduct an effective therapy of arrhythmia by study drug and minimize side effects.
- ПубликацияТолько метаданныеPhysiologically-based pharmacokinetic modeling: past, present and future (review) Физиологически обоснованное моделирование фармакокинетики: прошлое, настоящее, будущее (обзор)(2025) Bagaeva,N.S.; Evtyukhina, E. I.; Shchelgacheva, D. S.; Shohin, I. E.; Шохин, Игорь Евгеньевич
- ПубликацияОткрытый доступDevelopment and Validation of an HPLC-MS/MS Method for Quantification of Apixaban in Human Plasma(2024) Filonova, U. D.; Karnakova, P. K.; Karnakova, K. K.; Shohin, I. E.; Шохин, Игорь ЕвгеньевичIntroduction. Apixaban is an anticoagulant used in a number of thromboembolic diseases with an improved benefit-to-risk ratio, according to multiple clinical studies. Due to the prescription of apixaban as antithrombotic therapy in patients with COVID-19, an increase in its use has been observed. Thus, due to the widespread use of apixaban and the need to conduct pharmacokinetic and bioequivalence studies of the drug, it is important to develop and validate a simple and sensitive method for the quantitative determination of apixaban in human blood plasma. Aim. The aim of the study is to develop and validate a method for the determination of apixaban in human blood plasma using high-performance liquid chromatography with tandem mass selective detection (HPLC-MS/MS) for the subsequent bioanalytical study. Materials and methods. The determination of apixaban in human plasma was carried out by HPLC-MS/MS with rivaroxaban as an internal standard. The method of protein precipitation with acetonitrile was used as sample preparation. Mobile phase: 0.1 % solution of formic acid in water (eluent A); 0.1 % solution of formic acid in acetonitrile (eluent B). The total run time was 3.00 min. Column: Shim-pack Velox Biphenyl; 2.7 ‚?m; 50 ѓ? 2.1 mm. Ionization source: electrospray with positive ionization mode. MRM transitions: 460.15 ў?? 443.10 m/z (apixaban); 436.05 ў?? 144.95 m/z (rivaroxaban). Results and discussion. The developed method was validated in accordance with the EAEU requirements for the following parameters: selectivity, calibration curve, accuracy and precision, lower limit of quantitation, suitability of standard samples, matrix effect, recovery, stability, carry-over, dilution effects. The parameters met the acceptance criteria. Conclusion. The confirmed analytical range of the developed and validated method was 1.00ў??300.00 ng/mL in blood plasma. The method for determining apixaban in blood plasma is simple and sensitive. This method was tested during the analytical part of the bioanalytical study and can be used to conduct other pharmacokinetic studies of apixaban drugs.
- ПубликацияОткрытый доступHPLC-MS/MS method development and validation for the determination of tetradecapeptide in human plasma(2024) Tokareva, M. A.; Melnikov, E.; Belova, M.; Fisher, E. N.; Shohin, I. E.; Шохин, Игорь ЕвгеньевичIntroduction. The number of peptide drugs being developed and registered has increased in recent years. Therefore, modern analytical approaches and methods are required to determine these substances in biological matrices during pharmacokinetic studies. Peptides are structurally intermediate between small molecules and biopolymers, making it difficult to develop methods for determining them using High Performance Liquid Chromatography with Tandem Mass Spectrometry (HPLC-MS/MS). Peptide derivatization can help achieve optimal chromatographic separation and increase method sensitivity. Aim. To develop and validate a method for the determination of the tetradecapeptide (TDP) threonyl-glutamyl-lysyl-lysyl-arginyl-arginyl-glutamayl-threonyl-valyl-glutamyl-arginyl-glutamyl-lysyl-glutamate in human plasma by HPLC-MS/MS. Materials and methods. The determination of TDP in human plasma was performed by HPLC-MS/MS. Sample preparation included a combination of blood plasma protein precipitation with propionic acid solution in methanol, liquid-liquid extraction with chloroform, and peptide derivatization with propionic anhydride. Internal standard (IS) was threonyl-glutamyl-lysyl-lysyl-arginyl-arginyl-glutamayl-threonyl-leucyl-glutamyl-arginyl-glutamyl-lysyl-glutamate. Chromatographic separation was performed in gradient mode, eluent A was 0.1 % formic acid solution in water, eluent B was 0.1 % formic acid in acetonitrile. Column: Waters XBridge C18, 4.6 ѓ? 50 mm, 5 ‚?m. Ionization source was electrospray in positive mode. Multiple reaction monitoring (MRM) transitions for 4-substituted TDP propionate were: 681.30 ў?? 73.95 m/z, 681.30 ў?? 84.00 m/z, 681.30 ў?? 101.90 m/z, 681.30 ў?? 140.10 m/z, and for 4-substituted IS propionate: 686.00 ў?? 74.10 m/z, 686.00 ў?? 84.05 m/z, 686.00 ў?? 102.00 m/z, 686.00 ў?? 140.00 m/z. Results and discussion. Validation of the developed method was carried out in accordance with the requirements of Eurasian Economic Union and the following parameters were determined: selectivity, matrix effect, calibration curve, accuracy and precision, recovery, lower limit of quantification, sample carryover, stability. Conclusion. The method for the determination of TDP in human blood plasma by HPLC-MS/MS was developed and validated. The analytical range was 5.00ў??1000.00 ng/mL, allowing the method to be used to study TDP pharmacokinetics.
- ПубликацияОткрытый доступDerivatizing Agent Selection for Hydrophilic Lysine- and Arginine-Containing Tetradecapeptide Analysis in Human Plasma by RP HPLC-MS/MS(2025) Tokareva, M. A.; Melnikov, E.; Fisher, E. N.; Rodina, T. A.; Shohin, I. E.; Шохин, Игорь Евгеньевич
- ПубликацияОткрытый доступDevelopment and validation of a high-performance liquid chromatography with tandem mass spectrometry method for quantification of tofacitinib in human plasma(2024) Vetrova, E. S.; Karnakova, P. K.; Bagaeva, N. S.; Shohin, I. E.; Шохин, Игорь ЕвгеньевичIntroduction. The use of tofacitinib as a pharmacological treatment for rheumatoid arthritis remains relevant in the light of the predicted increase in prevalence of the disease. At the same time, due to the withdrawal of several foreign pharmaceutical companies from the Russian pharmaceutical market, there has been a heightened demand for domestically produced medications, including generic formulations of tofacitinib. Registration of generic drugs necessitates the conduct of bioanalytical studies. Development and validation of a method for quantifying the analyte in biosamples remains to be a crucial part of the bioequivalence studies. Aim. The aim of this research is to develop and validate a method for the quantitative determination of tofacitinib in human plasma using high-performance liquid chromatography as the separation system coupled with a tandem mass spectrometer for detection purposes. Materials and methods. Biosample preparation was based on plasma proteins precipitation using acetonitrile. Baricitinib was selected as an internal standard. The analytical range of the method was 1.00 to 200.00 ng/mL and was further expanded to 0.30 to 200.00 ng/mL during the analytical phase of the study. The mobile phase consisted of water and acetonitrile, both acidified with formic acid (0.1 % v/v). The stationary phase was a Phenomenex Kinetex C 18 column [100 ѓ? 3.0 mm, with a particle size of 5 ‚?m (Phenomenex, USA)]. Sample separation and detection were carried out using high-performance liquid chromatography coupled with a tandem mass spectrometry (HPLC-MS/MS), operating in positive ion mode. The multiple reaction monitoring (MRM) transitions selected for the analyte and the internal standard were 313.30 to 173.00 m/z and 371.90 to 186.00 m/z, respectively. Results and discussion. The developed assay was validated in accordance with the current requirements of regulatory documentation from the EAEU (Eurasian Economic Union), FDA (US Food and Drug Administration), and EMA (European Medicines Agency) with the following parameters being evaluated: selectivity, specificity, carry-over, matrix effect, recovery, calibration curve, lower limit of quantitation, accuracy, precision, stability. The validated method was applied in the analytical part of a bioequivalence study of domestically produced generic tofacitinib. Conclusion. A method for the quantitative determination of tofacitinib in human blood plasma with an analytical range of 0.30ў??200.00 ng/mL was developed and validated. Application of the assay during the analytical phase of bioequivalence study of generic tofacitinib confirms the possibility of using the method in similar bioanalytical investigations.