LC–MS–MS Quantitative Determination of Ursolic Acid in Human Plasma and Its Application to Pharmacokinetic Studies

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.

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LC–MS–MS Quantitative Determination of Brivudine in Human Plasma and Its Application to Pharmacokinetic Studies

Chromatographia ◽

10.1007/s10337-011-2001-y ◽

2011 ◽

Vol 73 (11-12) ◽

pp. 1089-1095 ◽

Cited By ~ 1

Author(s):

Xiang-Dong Peng ◽

Zhi-Rong Tan ◽

Hui-Zi Wu ◽

Gan Zhou ◽

Chen-Xian Guo ◽

...

Keyword(s):

Quantitative Determination ◽

Human Plasma ◽

Pharmacokinetic Studies

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Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma

Journal of Chromatographic Science ◽

10.1093/chromsci/bmz043 ◽

2019 ◽

Vol 57 (7) ◽

pp. 653-661

Author(s):

Ibrahim A Naguib ◽

Eglal A Abdelaleem ◽

Aml A Emam ◽

Fatma F Abdallah

Keyword(s):

Acetic Acid ◽

Quantitative Determination ◽

Human Plasma ◽

High Performance ◽

Pyridostigmine Bromide ◽

Pharmacokinetic Studies ◽

Related Substances ◽

Ich Guidelines ◽

Developing System

Abstract A green, accurate and specific high-performance thin-layer chromatographic (HPTLC) method was developed and validated for simultaneous quantitative determination of pyridostigmine bromide (PR), impurity B (IMP B);3-hydroxy-N-methylpyridinium bromide and impurity A (IMP A); pyridin-3-yl-dimethylcarbamate. The two pharmacopeial impurities are also its main inactive metabolites. Furthermore, IMP B is known to be its alkaline-induced degradation product. Achievable separation of the studied components required silica gel HPTLC F254 plates as a stationary phase and acetone: acetic acid (80:20, v/v) as a developing system. Scanning of the separated bands was done at 260 nm. According to green solvent selection guidelines, acetone and acetic acid are eco-friendly solvents. Validation of the developed method was insured by its acquiesce to international conference on harmonization (ICH) guidelines. The introduced method was successfully achieved for the quantitative determination of PR, IMP B and IMP A in the range of 0.4–10, 2–11 and 0.4–3.5 μg/band, respectively. Successful application of the developed method was done for determination of PR in human plasma in the range of 0.6–10 μg/band, so the proposed HPTLC can be applied in the pharmacokinetic studies. The studied drug was also analyzed in Mestinon® tablets using the developed method.

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

Drug development & registration ◽

10.33380/2305-2066-2019-8-2-108-114 ◽

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.

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Simple HPLC Method for Quantitative Determination of Carbinoxamine in Human Plasma: Application in Pharmacokinetic Studies and Therapeutic Drug Monitoring

Drug Research ◽

10.1055/a-0787-1302 ◽

2019 ◽

Vol 69 (06) ◽

pp. 342-347

Author(s):

Soha M. El-Masry ◽

Rasha M. El-Morsi

Keyword(s):

Therapeutic Drug Monitoring ◽

Quantitative Determination ◽

Human Plasma ◽

Drug Monitoring ◽

Hplc Method ◽

Therapeutic Drug ◽

Pharmacokinetic Studies ◽

Simple Liquid ◽

Limit Of Quantitation

AbstractA sensitive, specific and cost-effective HPLC method was developed for quantitative determination of carbinoxamine in human plasma using liquid chromatography with ultraviolet detection. A simple liquid–liquid extraction by ethyl acetate was used to extract carbinoxamine from human plasma. Satisfactory separation was achieved by a mobile phase consisting of 20 mM ammonium dihydrogen orthophosphate containing 0.01% triethyl amine (pH adjusted to 3 by using phosphoric acid) and acetonitrile in ratio of (75:25, v/v) at a flow rate of 0.9 mL/min on Hypersil® BDS C18 column (250×4.6 mm, 5 μm) column. The UV detector was set at 260 nm. The developed method was validated in human plasma with a lower limit of quantitation of 5 ng/mL for carbinoxamine. Linearity was demonstrated over the concentration range 5–200 ng/mL. The observed within- and between-day assay precision ranged from 1.902 to 14.90%; accuracy varied between 98.87 and 108.0%. This method can be used suitably for pharmacokinetic studies and in therapeutic drug monitoring in patients treated with carbinoxamine.

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