scholarly journals Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method

2020 ◽  
Vol 9 (4) ◽  
pp. 146-154
Author(s):  
T. N. Komarov ◽  
I. E. Shohin ◽  
M. A. Tokareva ◽  
O. A. Archakova ◽  
D. S. Bogdanova ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Blood Plasma ◽  
Human Plasma ◽  
High Performance ◽  
Protein Precipitation ◽  
Human Blood Plasma ◽  
Pharmacokinetic Studies ◽  
Limit Of Quantification ◽  
Development And Validation

Introduction. B-cell malignancies of the plasma cell leads to the second most spread hematological malignancy disease, called multiple myeloma. Pomalidomide is used in case of previous multiple myeloma ineffective treatment. Pomalidomide is a thalidomide synthetic derived, approved as immunomodulatory drug by the Food and Drug Administration (FDA). Nowadays, detection of pomalidomide in blood plasma by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) is not spread. Moreover, the detection and the experimental setting accumulated data are varying greatly. This investigation provides development and validation of pomalidomide aiming to determine human blood plasma by HPLC-MS/MS method. The samples were processed by methanol protein precipitation.Aim. The aim of this study is to develop a method for the pomalidomide in human plasma by HPLC-MS/MS for pharmacokinetic studies.Materials and methods. Determination of pomalidomide in plasma by HPLC-MS/MS. The samples were processed by methanol protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, spike recovery, lower limit of quantification, detection limit, carry-over and stability. Conclusion. The method of the determination of pomalidomide in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 1,00 – 500,00 ng/ml. Method could be applied to pomalidomide determination in plasma for PK and BE studies.

scholarly journals Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-UV Method

2020 ◽  
Vol 9 (2) ◽  
pp. 133-139
Author(s):  
T. N. Komarov ◽  
I. E. Shohin ◽  
O. A. Miskiv ◽  
D. S. Bogdanova ◽  
A. V. Aleshina ◽  
...  
Keyword(s):  
Quantitative Determination ◽  
Simultaneous Determination ◽  
Human Plasma ◽  
Active Metabolite ◽  
Protein Precipitation ◽  
Human Blood Plasma ◽  
Pharmacokinetic Studies ◽  
Validation Parameters ◽  
Development And Validation

Introduction. Viral infections are a serious problem that occurs during the use of immunosuppressants in preparation for organ transplantation and in the postoperative period. Cytomegalovirus (CMV) infection is one of the main causes of diseases in people with weakened immune systems. It has a direct impact on one’s body and makes it more likely to reject a transplanted organ. Antiviral drugs are used to treat and prevent this infectious disease. Valganciclovir is a prodrug whose active metabolite is ganciclovir. Valganciclovir is the drug of choice in the treatment of CMV infections. Currently, there are no researches on the matter of simultaneous determination of both valganciclovir and ganciclovir in human blood plasma by means of high-performance liquid chromatography (HPLC) with ultraviolet detection. This research delivers a thorough description of development and validation of a particular method for simultaneous determination of valganciclovir and ganciclovir in the plasma after sample preparation by the method of protein precipitation.Aim. The aim of this study is to develop method for the quantitative determination of valganciclovir and its active metabolite ganciclovir in human plasma by HPLC-UV for pharmacokinetic studies.Materials and methods. Quantitative determination of tadalafil in plasma by HPLC-UV. A sample was prepared using protein precipitation.Results and discussion. This method was validated by next validation parameters: selectivity, matrix effect, calibration curve, accuracy, precision, lower limit of quantification, carry-over and stability.Conclusion. The method of the quantitative determination of valganciclovir and its active metabolite ganciclovir in human plasma was developed and validated by HPLC-UV. The analytical range of the was 5,0–1000,0 ng/ml for valganciclovir and 100,0–10000,0 ng/ml for ganciclovir in plasma. Method could be applied to determination of valganciclovir and ganciclovir in plasma for PK and BE studies.

scholarly journals Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method

2021 ◽  
Vol 10 (1) ◽  
pp. 120-128
Author(s):  
T. N. Komarov ◽  
I. E. Shohin ◽  
M. A. Tokareva ◽  
O. A. Archakova ◽  
D. S. Bogdanova ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Human Plasma ◽  
High Performance ◽  
Biological Fluids ◽  
Detection Methods ◽  
Pharmacokinetic Studies ◽  
Limit Of Quantification ◽  
Carry Over

Introduction. Currently, physicochemical methods of quantification are actively used to determine the content of drugs in biological fluids. High-performance liquid chromatography with various detection methods is particularly widespread. One of the most difficult practical tasks is the chromatographic separation of so-called poorly retained compounds – drug substances poorly retained on the chromatographic column. Valganciclovir and Ganciclovir are among such substances. Aim. The aim of this study is to develop a method for valganciclovir and ganciclovir in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies.Materials and methods. Determination of valganciclovir and ganciclovir in plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, recovery, lower limit of quantification, carry-over and stability.Conclusion. The method of the determination of valganciclovir and ganciclovir in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 5.00–1000.00 ng/ml for valganciclovir and 50.00–10000.00 ng/ml for ganciclovir. Method could be applied to valganciclovir and ganciclovir determination in plasma for PK and BE studies.

scholarly journals Development and Validation of Tadalafil Determination in Human Plasma by HPLC-MS Method

2019 ◽  
Vol 8 (2) ◽  
pp. 108-114
Author(s):  
D. S. Bogdanova ◽  
T. N. Komarov ◽  
I. E. Shohin ◽  
E. S. Melnikov ◽  
O. A. Miskiv ◽  
...  
Keyword(s):  
Quantitative Determination ◽  
Human Plasma ◽  
Solid Phase ◽  
Protein Precipitation ◽  
Clinical Samples ◽  
Pharmacokinetic Studies ◽  
Limit Of Quantification ◽  
Validation Parameters ◽  
Tandem Mass Spectrometric

Introduction. Tadalafil is a drug used to treat erectile dysfunction. For the quantitative determination of tadalafil in human plasma are used methods of high performance liquid chromatography with ultraviolet and tandem mass spectrometric detection, during the analytical part of pharmacokinetic studies. In the majority of the considered methods the method of liquid-liquid extraction and the method of solid-phase extraction are used, these methods are difficult and expensive. Therefore, the method of protein precipitation was considered as sample preparation. This method is simple and there is important to analysis a lot of clinical samples in bioequivalence studies.Aim. The aim of this study is to develop method for the quantitative determination of tadalafil in human plasma by HPLC-MS for the analytical part of pharmacokinetic studies.Materials and methods. Quantitative determination of tadalafil in plasma by HPLC-MS. A sample was prepared using acetonitrile protein precipitation.Results and discussion. This method was validated by next validation parameters: selectivity, matrix effect, calibration curve, accuracy, precision, lower limit of quantification, carry-over and stability.Conclusion. The method of the quantitative determination of tadalafil in human plasma was developed and validated by HPLC-MS. The analytical range of the was 5,00–1000,00 ng/ml tadalafil in plasma. Method could be applied to determination of tadalafil in plasma for PK and BE studies.

scholarly journals Development and Validation of Tranexamic Acid Determination in Human Plasma by HPLC-MS/MS method

2021 ◽  
Vol 10 (2) ◽  
pp. 120-127
Author(s):  
A. V. Aleshina ◽  
T. N. Komarov ◽  
O. A. Archakova ◽  
D. S. Shchelgacheva ◽  
N. S. Bagaeva ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Tranexamic Acid ◽  
Human Plasma ◽  
Analytical Method ◽  
High Performance ◽  
Human Blood Plasma ◽  
Pharmacokinetic Studies ◽  
Acid Determination

Introduction. Tranexamic acid is one of the most common drugs used to stop bleeding after trauma, in surgery and gynecology. The most common analytical method for the determination of this compound is reversed-phase high-performance liquid chromatography (HPLC). However, this compound belongs to the group of so-called poorly retained compounds due to its chemical structure. It is necessary to develop an analytical method that will allow the determination of tranexamic acid in human blood plasma with the least time, resource costs and without the use of specialized columns.Aim. The aim of this study is to develop a method for tranexamic acid in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies.Materials and methods. Determination of tranexamic acid in plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, recovery, lower limit of quantification, carry-over effect and stability.Conclusion. The method of the determination of tranexamic acid in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 100.00–15000.00 ng/ml. Method could be applied to tranexamic acid determination in plasma for pharmacokinetics and bioequivalence studies.

Validation of Simvastatin Analysis Methods in Human Blood Plasma (In Vitro) Using HPLC-UV Detector

2018 ◽  
Vol 8 (2) ◽  
Author(s):  
Iyan Sopyan ◽  
Cynthia Jaya ◽  
Driyanti Rahayu
Keyword(s):  
Blood Plasma ◽  
Human Plasma ◽  
Disease Risk ◽  
Protein Precipitation ◽  
Precipitation Method ◽  
Human Blood Plasma ◽  
Analysis Method ◽  
Uv Detector ◽  
Number Of Patients ◽  
System Suitability

The use of simvastatin (SV) increases along with the increasing number of patients with hyperlipidemia and cardiovascular disease risk factors. Consequently, this condition leads to the increasing need of analytical determination of SV in blood plasma. Analysis of SV in human plasma using protein precipitation method and HPLC with UV detector has not been reported. This research was purpose to find out the rapid, accurate, and valid of SV analysis method in human plasma. In this research plasma samples were treated with protein precipitation method. The analyte was then analyzed using HPLC with C18 column 250x4 mm and 5 µm of particle size, the mobile phase contained of phosphate buffer 0.01 M (pH 4.0) and acetonitrile 30:70 v/v with flow rate 1 mL/minute, and detected at 239 nm. The analysis method was validated based on some parameters, such as selectivity, accuracy, precision, repeatability, linearity, LOD, LOQ, and system suitability. The result showed selectivity represented by Rs was 2.870, repeatability by its CV less than 2%, and linearity by its coefficient correlation (r) 0.9992 for concentration range 0.08-0.32 ppm. Based on chromatogram peak area, LOD and LOQ were 0.0132 and 0.0440 ppm respectively, accuracy and precision were 86.25-89.36% and 0.66-1.81% were obtained. The result of system suitability test from retention time and chromatogram peak area showed by its CV less than 2%. The analysis method was proved to be valid for SV analysis in human plasma

Development and Validation of a New Method for the Determination of Anti-hepatitis C Agent Simeprevir in Human Plasma using HPLC with Fluorescence Detection

2020 ◽  
Vol 16 (4) ◽  
pp. 428-435
Author(s):  
Ahmed F.A. Youssef ◽  
Yousry M. Issa ◽  
Kareem M. Nabil
Keyword(s):  
Hepatitis C ◽  
Human Plasma ◽  
Fluorescence Detection ◽  
Internal Standard ◽  
Protein Precipitation ◽  
Assay Method ◽  
Fluorescence Detector ◽  
Limit Of Quantification ◽  
Relative Standard

Background: Simeprevir is one of the recently discovered drugs for treating hepatitis C which is one of the major diseases across the globe. Objective: The present study involves the development of a new and unique High-Performance Liquid Chromatography (HPLC) method using fluorescence detection for the determination of simeprevir (SIM) in human plasma. Methods: Two methods of extractions were tested, protein precipitation using acetonitrile and liquidliquid extraction. A 25 mM dipotassium hydrogen orthophosphate (pH 7.0)/ACN (50/50; v/v), was used as mobile phase and C18 reversed phase column as the stationary phase. The chromatographic conditions were optimized and the concentration of simeprevir was determined by using the fluorescence detector. Cyclobenzaprine was used as an internal standard. Results: Recovery of the assay method based on protein precipitation was up to 100%. Intra-day and inter-day accuracies range from 92.30 to 107.80%, with Relative Standard Deviation (RSD) range 1.65-8.02%. The present method was successfully applied to a pharmacokinetic study where SIM was administered as a single dose of 150 mg SIM/capsule (Olysio®) to healthy individuals. Conclusion: This method exhibits high sensitivity with a low limit of quantification 10 ng mL-1, good selectivity using fluorescence detection, wide linear application range 10-3000 ng mL-1, good recovery and highly precise and validation results. The developed method can be applied in routine analysis for real samples.

scholarly journals Development and validation of method for quantitative determination of sildenafil and n-desmethyl sildenafil by HPLC-MS/MS in human blood plasma

2017 ◽  
Vol 0 (1 (5)) ◽  
pp. 22-32 ◽  
Author(s):  
Igor Kuznetsov ◽  
Helen Naumenko ◽  
Nataliia Reznichenko ◽  
Andrey Kostiuk ◽  
Roman Savyak ◽  
...  
Keyword(s):  
Quantitative Determination ◽  
Blood Plasma ◽  
Human Blood ◽  
Human Blood Plasma ◽  
Development And Validation

HPTLC Separation of a Hepatoprotective Combination in Pharmaceutical Formulation and Human Plasma

2020 ◽  
Vol 58 (5) ◽  
pp. 411-417
Author(s):  
Maimana A Magdy ◽  
Rehab M Abdelfatah
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Limit Of Detection ◽  
Pharmaceutical Formulation ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Spiked Plasma ◽  
Significant Difference ◽  
Developing System

Abstract A binary mixture of Silymarin (SR) and Vitamin E (VE) acetate, of an antioxidant and a hepatoprotective effect, has been analyzed using a sensitive, selective and economic high performance thin layer chromatographic (HPTLC) method in their pure forms, pharmaceutical formulation and spiked human plasma. SR and VE were separated on 60F254 silica gel plates using hexane:acetone:formic acid (7:3:0.15, v/v/v) as a developing system with UV detection at 215 nm. The method was evaluated for linearity, accuracy, precision, selectivity, limit of detection (LOD) and limit of quantification (LOQ). SR and VE were detected in the linear range of 0.2–2.5 and 0.2–4.5 μg/band, respectively. Method validation was done as per ICH guidelines and acceptable results of accuracy of 99.86 ± 1.190 and 100.22 ± 1.609 for SR and VE, respectively were obtained. The method has been successfully applied for determination of the studied drugs in their pharmaceutical formulation without any interference from excipients, and in spiked plasma samples. Results obtained by the developed HPTLC-densitometric method were statistically compared to those obtained by the reported HPLC methods and no significant difference was found between them.

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