Principles and Applications of LC-MS/MS for the Quantitative Bioanalysis of Analytes in Various Biological Samples

Kang, Ju‐Seop

doi:10.5772/32085

Cited by 31 publications

(22 citation statements)

References 176 publications

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“…In this regard, LC‐MS/MS is the technique of choice as it provides high selectivity based on MRM analysis, sensitivity, speed, and is applicable to a broad spectrum of analytes. These attributes have led to its enormous growth and is now routinely used to support clinical, therapeutic drug monitoring, doping control and toxicological studies . Thus in the present work, an LC‐MS/MS assay with the required sensitivity, selectivity and throughput was developed and validated for the determination of carglumic acid in human plasma.…”

Section: Resultsmentioning

confidence: 99%

“…These attributes have led to its enormous growth and is now routinely used to support clinical, therapeutic drug monitoring, doping control and toxicological studies. [13] Thus in the present work, an LC-MS/MS assay with the required sensitivity, selectivity and throughput was developed and validated for the determination of carglumic acid in human plasma. The method was developed through an integrated optimization of all three stages of quantitative bioanalysis, i.e., sample preparation, chromatography, and mass detection.…”

Section: Resultsmentioning

confidence: 99%

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Challenges in optimizing sample preparation and LC‐MS/MS conditions for the analysis of carglumic acid, an N‐acetyl glutamate derivative in human plasma

Sharma

Shah

Sanyal

et al. 2015

Drug Testing and Analysis

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This paper describes a systematic approach to overcoming challenges in developing a robust and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for reliable and precise determination of carglumic acid in human plasma. Sample extraction was tested on several reversed-phase solid-phase extraction (SPE) sorbents with different chemistries, such as hydrophobic C18, hydrophilic-lipophilic balance, and mixed-mode cation and anion exchange. The best recovery under the optimized extraction conditions was obtained with Oasis MAX (30 mg, 1cc) mixed-mode anion exchange (~ 50%) cartridge, compared to other sorbents from 100 μL plasma sample. Complete analytical separation of carglumic acid and carglumic acid-13C5 15N as an internal standard (IS) from endogenous plasma components was achieved on ACE 5CN (150 × 4.6 mm, 5 µm) column under isocratic conditions using acetonitrile:methanol (50:50, v/v) - 0.1% acetic acid in water [80:20, v/v] as the mobile phase. The deprotonated precursor → product ion transitions for carglumic acid (189/146) and IS (195/152) were monitored in the negative ionization mode on a triple quadrupole mass spectrometer. The regression curves were linear over a concentration range of 6.00-6000 ng/mL (r(2) ≥ 0.9987). Matrix effect was evaluated in terms of IS-normalized matrix factors, which ranged from 0.95 to 1.01 across four quality control levels. Intra- and inter-batch accuracy and precision, and the stability of carglumic acid in spiked plasma samples were assessed under different conditions. The method was applied to assess the pharmacokinetics of 100 mg/kg body weight carglumic acid in a healthy Indian subject.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Challenges in optimizing sample preparation and LC‐MS/MS conditions for the analysis of carglumic acid, an N‐acetyl glutamate derivative in human plasma

Sharma

Shah

Sanyal

et al. 2015

Drug Testing and Analysis

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show abstract

“…45 Triple stage quadrapole and ion trap mass spectrometers are presently used for this technique, because of their sensitivity and selectivity. 54 For the detection of a wide range of polar water soluble compounds present in water, HPLC-MS-MS is a powerful technique. 56 A liquid chromatographic-tandem mass spectrometric method using an Xterra MS C 18 chromatographic column (100mm × 2.1mmi.d.…”

Section: Lc-ms-msmentioning

confidence: 99%

Impurities in Pharmaceuticals- A Review.

.¹,

Deshmukh²,

Chaudhari³

2013

JCPR

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Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed due to any side reactions. The impurity may be developed either during formulation, or upon aging of both API's and formulated API's in medicines. The presence of these unwanted chemicals, even in small amount, may influence the efficacy and safety of the pharmaceutical products. The control of impurities is currently a critical issue to the pharmaceutical industry. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. The advent of hyphenated techniques has revolutionized impurity profiling, by not only separation but structural identification of impurities. This review highlights the different types of impurities and various methods for isolation, separation and characterization of impurities.

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“…However, the feasibility of collecting urine samples is being debated in the case of sampling surveillance. 4 As a result of concerns in privacy violations in sampling surveillance, the truth process from the sample can still be doubted . This research will be carried out to obtain the MDMA bioanalysis method in DBS using liquid-liquid micro-extraction method using gas chromatography mass spectrometry (GC-MS) with ephedrine HCl as internal standard.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of 3,4-Methylenedioxymethamphetamine Analysis Methods in Dried Blood Spot Sample Using Gas Chromatography-Mass Spectrometry

Harahap¹,

Julio²,

Kuswardani³

2019

Int Res J Pharm

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Objective: This research was carried out to obtain the MDMA bioanalysis method in DBS using liquid-liquid micro-extraction method using gas chromatography mass spectrometry (GC-MS) with the standard in Ephedrine. Methods: The blood was spotted on DBS paper and dried prior to analysis. The instrument used is Shimadzu GCMS-QP2010 Ultra Mass Chromatography Gas, with an HP-5 MS capillary column length of 30 m, 0.25 mm diameter and a film thickness of 0.25 μm. The mobile phase used is 99.99% Helium gas and split less injection mode. Results: The optimum chromatography condition for MDMA analysis in DBS is the HP-5 MS capillary column with a length of 30 m; inner diameter 0.25 mm; Helium mobile phase 99.999%; flow rate of 0.8 mL / minute; MS detection at m / z 58.00 and 135.00 and ephedrine HCl as internal standard. Sample preparation used a liquid-liquid micro-extraction method with methanol as solvent then it was sonicated or 15 minutes then dried with Nitrogen gas and reconstituted with 40 μL of ethyl acetate then centrifuged for 5 minutes with 3000 rpm. Conclusion: The developed method for determination of MDMA in DBS fulfilled validation based on EMEA bioanalytical guidelines in 2011 for linearity, LLOQ limits, accuracy and precision, selectivity, carry over, matrix effect and stability. The method obtained was linear in the concentration range 25.0-500.0 ng / mL with r> 0.999.

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Principles and Applications of LC-MS/MS for the Quantitative Bioanalysis of Analytes in Various Biological Samples

Cited by 31 publications

References 176 publications

Challenges in optimizing sample preparation and LC‐MS/MS conditions for the analysis of carglumic acid, an N‐acetyl glutamate derivative in human plasma

Challenges in optimizing sample preparation and LC‐MS/MS conditions for the analysis of carglumic acid, an N‐acetyl glutamate derivative in human plasma

Impurities in Pharmaceuticals- A Review.

Development and Validation of 3,4-Methylenedioxymethamphetamine Analysis Methods in Dried Blood Spot Sample Using Gas Chromatography-Mass Spectrometry

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