Development and validation of a sensitive method for hydromorphone in human plasma by normal phase liquid chromatography–tandem mass spectrometry

Weng, Naidong; Jiang, Xuxian; Newland, Kirk; Coe, R.A.J.; Lin, Patrick; Lee, Jean

doi:10.1016/s0731-7085(00)00352-6

Cited by 37 publications

(20 citation statements)

References 21 publications

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“…2. The selection of silica column and aqueous-organic mobile phase for quantitative analysis of paroxetine was based on our previous experiences for analyzing other polar compounds in biological fluids (Naidong, et al, 1999(Naidong, et al, , 2000Shou et al, 2001Shou et al, , 2002aChen et al, 2002;Eerkes et al, 2002a,b;Pelzer et al, 2002;Eerkes and Naidong, 2003). Bare silica columns operated with low aqueous-high organic mobile phases are viable means of analyzing polar compounds in biological fluid.…”

Section: The [M+h]mentioning

confidence: 99%

Development and validation of a hydrophilic interaction liquid chromatography–tandem mass spectrometric method for the analysis of paroxetine in human plasma

Weng

Eerkes

2003

Biomedical Chromatography

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A sensitive, simple, fast and rugged hydrophilic interaction liquid chromatography-tandem mass spectrometry (HILIC-MS/MS) method for the determination of paroxetine was developed and validated over curve range 0.050-50 ng/mL using only 0.4 mL plasma. This is the first published LC-MS/MS method and the low limit of quantitation of this method is 10-fold lower than previously published methods. A simple liquid-liquid extraction method using methyl-tert butyl ether (MTBE) as the extraction solvent was used to extract paroxetine and the internal standard (IS) fentanyl-d(5) from plasma. The extract was evaporated to dryness, reconstituted and injected onto a silica column using a low aqueous-high organic mobile phase. The chromatographic run time was 2.0 min per injection, with retention times of 1.1 and 1.2 min for paroxetine and IS, respectively. The detection was by monitoring paroxetine at m/z 330 --> 192 and IS at m/z 342 --> 188, respectively. The inter-day precision and accuracy of the quality control (QC) samples were <5.0% relative standard deviation (RSD) and <2.9% relative error (RE). This method can be used for supporting therapeutical drug monitoring and pharmacokinetic or drug-drug interaction studies.

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Section: The [M+h]mentioning

confidence: 99%

Development and validation of a hydrophilic interaction liquid chromatography–tandem mass spectrometric method for the analysis of paroxetine in human plasma

Weng

Eerkes

2003

Biomedical Chromatography

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“…How fast is too fast? Phase II metabolites (glucuronide, and sulfateand glutathione-conjugation products) and pro-drugs are notoriously unstable in the LC-MS interface and are easily fragmented back to the drugs [146][147][148]. Without adequate chromatographic retention and separation between the drug and its Phase II metabolites or pro-drugs, the drug concentration can be easily over-estimated for the incurred samples.…”

Section: Methods Validation and Critical Issues During Sample Analysismentioning

confidence: 99%

Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods

Zhou¹,

Song²,

Tang³

et al. 2005

CPA

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Swift growth in the use of LC-MS/MS for the analysis of drugs in biological matrices has been compelled by the need for timely and high-quality data at many stages in drug discovery and development process: from high throughput screening of drug candidates and rapid data generation for pre-clinical studies to almost 'real-time' analysis of clinical samples. Prompt and rational method development, validation, and transfer play a pivotal role in achieving the goals of "faster, better, and cheaper" for pharmacokinetic studies since this could easily account for more than 50% of the time and labor resources for a moderate-sized project. Strategy for rational method development, validation and transfer has been largely kept as institutional knowledge but rarely appeared in literature. In this review article, strategies for developing and validating robust high throughput LC-MS/MS methods will be critically reviewed and discussed. Automated sample preparation, fast chromatography, minimization of matrix effects, and strategy of narrowing the gap between validation and incurred sample analysis are just a few topics covered in this review. Other interesting approaches for improving method efficiency and ruggedness such as direct injection SPE and liquid/liquid extracts as well as multiplexing of LC columns will also be discussed. Potential pitfalls during method development and validation are pointed out. At the end, the question "how fast is fast enough and how fast is too fast?" will be answered after considering all aspects of the method development and validation.

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“…The chromatographic run time was 2.0 min per injection with a LOD of 0.05 ng/mL. Similar methodologies using different MRM were further extended for the determinations of tiapride [37], clonidine [38], fluoxetine, norfluoxetine [39], fluconazole [40], omeprazole, 5-OH omeprazole [41], loratadine (LOR), descarboethoxy-LOR [42], hydromorphone [43], levosulpiride [44], levofloxacin [45], carvedilol [46], and muraglitazar [47] in biological fluids where the analytes were extracted into an organic solvent by vortex-mixing and the organic layer was evaporated to dryness under nitrogen and then reconstituted. By LLE, the analytes are extracted through the partitioning between the aqueous and organic layers and the organic extracts need to be transferred for solvent evaporation and reconstitution.…”

Section: Underivatized Silica Hilic-ms/msmentioning

confidence: 99%

Potential of HILIC‐MS in quantitative bioanalysis of drugs and drug metabolites

Hsieh¹

2008

J of Separation Science

117

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One fundamental requirement for many lead optimization processes is the need for bioanalytical support within pharmaceutical drug discovery and development. Currently, most bioanalytical methods for pharmaceutical analysis employ HPLC coupled with MS/MS. The combination of HPLC and MS/MS detection frequently offers the complete resolution of the dosed compounds from their metabolites and the endogenous interferences to avoid extra efforts for chemical separation and sample clean-up procedures resulting in higher-throughput assays for a series of new chemical entities (NCEs). Hydrophilic interaction chromatography (HILIC) has been demonstrated to be a powerful technique for the retention of polar analytes offering a difference in selectivity compared to traditional RP chromatography. This review summarizes the HILIC-MS/MS methods for the trace quantitative determinations of the drug compounds and their metabolites to support both in vitro and in vivo experiments. The challenges on performing HILIC-MS/MS assays such as matrix ionization suppression and the potential for endogenous interferences are also presented.

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Development and validation of a sensitive method for hydromorphone in human plasma by normal phase liquid chromatography–tandem mass spectrometry

Cited by 37 publications

References 21 publications

Development and validation of a hydrophilic interaction liquid chromatography–tandem mass spectrometric method for the analysis of paroxetine in human plasma

Development and validation of a hydrophilic interaction liquid chromatography–tandem mass spectrometric method for the analysis of paroxetine in human plasma

Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods

Potential of HILIC‐MS in quantitative bioanalysis of drugs and drug metabolites

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