An improved LC–ESI–MS–MS method for simultaneous quantitation of rosiglitazone and N-desmethyl rosiglitazone in human plasma

O’Maille, Grace; Pai, Sudhakar M.; Tao, Xiaolu; Douglas, George T.; Jenkins, Rand

doi:10.1016/j.jpba.2008.08.001

Cited by 25 publications

(9 citation statements)

References 11 publications

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“…The mean C max of N-DmR was 114 ± 20.3 ng/ml at T max (6 h; range, 4-8 h), and the AUC 0−t values were 2010 ± 327 ng h/ml. The pharmacokinetic parameters of rosiglitazone and N-DmR were similar to those reported in the literature [5][6][7]16,17]. Although the plasma concentration of p-OH-R was low compared with that of N-DmR, p-OH-R was detectable and sufficiently measurable at all sampling points except for the first sampling time, 0.33 h (Fig.…”

Section: Clinical Applicationsupporting

confidence: 85%

“…However, these methods require time-consuming and laborious extraction procedures or relatively large sample volumes (∼1 ml), as well as lengthy chromatographic run times, limiting their throughput capacity and sensitivity. Liquid chromatography (LC)-tandem mass spectrometry (MS/MS) methods provide rapid and sensitive simultaneous determination of rosiglitazone and NDmR [7,16], but are only semi-quantitative for N-DmR; due to lack [17] reported an LC-MS/MS method that uses liquid-liquid extraction to simultaneously quantify rosiglitazone and N-DmR in human plasma. However, no previous reports have described the simultaneous LC-MS/MS quantification of rosiglitazone, N-DmR, and p-OH-R in human plasma.…”

Section: Introductionmentioning

confidence: 99%

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Simultaneous quantification of rosiglitazone and its two major metabolites, N-desmethyl and p-hydroxy rosiglitazone in human plasma by liquid chromatography/tandem mass spectrometry: Application to a pharmacokinetic study

Kim

Lee

Yeo

et al. 2009

Journal of Chromatography B

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Section: Clinical Applicationsupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Simultaneous quantification of rosiglitazone and its two major metabolites, N-desmethyl and p-hydroxy rosiglitazone in human plasma by liquid chromatography/tandem mass spectrometry: Application to a pharmacokinetic study

Kim

Lee

Yeo

et al. 2009

Journal of Chromatography B

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“…When the water immiscible extraction solvent is applied, analytes are efficiently desorbed and the solvent is collected. Several SLE bioanalytical LC‐MS/MS assays have been developed and validated using SLE plates packed with diatomaceous earth material (Wang et al , ; O'Maille et al , ; Jiang et al , ; Pan et al , ). The SLE procedure developed for the isolation of fluoxetine, norfluoxetine and fluoxetine‐d 5 (IS) from human plasma was simple and automated.…”

Section: Resultsmentioning

confidence: 99%

Simultaneous determination of fluoxetine and its major active metabolite norfluoxetine in human plasma by LC‐MS/MS using supported liquid extraction

Liu

Emm

Yeleswaram

2011

Biomedical Chromatography

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A rapid, sensitive and selective bioanalytical method was developed for the simultaneous determination of fluoxetine and its primary metabolite norfluoxetine in human plasma. Sample preparation was based on supported liquid extraction (SLE) using methyl tert-butyl ether to extract the analytes from human plasma. Chromatography was performed on a Synergi 4 μ polar-RP column using a fast gradient. The ionization was optimized using ESI (+) and selectivity was achieved by tandem mass spectrometric analysis using MRM functions, m/z 310 → 44 for fluoxetine, m/z 296 → 134 for norfluoxetine and m/z 315 → 44 for fluoxetine-d5 (internal standard). The method is linear over the range of 0.05-20 ng/mL (using a human plasma sample volume of 0.1 mL) with a coefficient determination of greater than 0.999. The method is accurate and precise with intra-batch and inter-batch accuracy (%bias) of < ± 15% and precision (%CV) of <15% for both analytes. A run time of 4 min means a high throughput of samples can be achieved. To our knowledge, this method appears to be the most sensitive one reported so far for the quantitation of fluoxetine and norfluoxetine and can be used for routine therapeutic drug monitoring or pharmacokinetic studies.

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“…Similar to the traditional LLE, SLE provides very clean extracts with a high recovery. Several SLE bioanalytical LC-MS/MS or GC-MS assays have been developed and validated using SLE packed with diatomaceous earth material [16,17,18,19,20]. …”

Section: Introductionmentioning

confidence: 99%

Automatic Supported Liquid Extraction (SLE) Coupled with HILIC-MS/MS: An Application to Method Development and Validation of Erlotinib in Human Plasma

2010

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A novel bioanalytical method was developed and validated for the quantitative determination of erlotinib in human plasma by using the supported liquid extraction (SLE) sample cleanup coupled with hydrophilic interaction liquid chromatography and tandem mass spectrometric detection (HILIC-MS/MS). The SLE extract could be directly injected into the HILIC-MS/MS system for analysis without the solvent evaporation and reconstitution steps. Therefore, the method is simple and rapid. In the present method, erlotinib-d6 was used as the internal standard. The SLE extraction recovery was 101.3%. The validated linear curve range was 2 to 2,000 ng/mL based on a sample volume of 0.100-mL, with a linear correlation coefficient of > 0.999. The validation results demonstrated that the present method gave a satisfactory precision and accuracy: intra-day CV < 5.9% (<8.4% for the lower limit of quantitation, LLOQ) with n = 6 and the accuracy of 98.0–106.0%; inter-day CV < 3.2% (<1.5% for LLOQ) with n = 18 and the accuracy of 100.0–103.2%. A dilution factor of 10 with blank plasma was validated for partial volume analysis. The stability tests indicated that the erlotinib in human plasma is stable for three freeze-thaw cycles (100.0–104.5% of the nominal values), or 24-h ambient storage (100.0–104.8% of the nominal values), or 227-day frozen storage at both -20 °C (91.5–94.5% of the nominal values) and -70 °C (93.3–93.8% of the nominal values). The results also showed no significant matrix effect (<6.3%) even with direct injection of organic extract into the LC-MS/MS system. The validated method has been successfully applied to support a clinical study.

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An improved LC–ESI–MS–MS method for simultaneous quantitation of rosiglitazone and N-desmethyl rosiglitazone in human plasma

Cited by 25 publications

References 11 publications

Simultaneous quantification of rosiglitazone and its two major metabolites, N-desmethyl and p-hydroxy rosiglitazone in human plasma by liquid chromatography/tandem mass spectrometry: Application to a pharmacokinetic study

Simultaneous quantification of rosiglitazone and its two major metabolites, N-desmethyl and p-hydroxy rosiglitazone in human plasma by liquid chromatography/tandem mass spectrometry: Application to a pharmacokinetic study

Simultaneous determination of fluoxetine and its major active metabolite norfluoxetine in human plasma by LC‐MS/MS using supported liquid extraction

Automatic Supported Liquid Extraction (SLE) Coupled with HILIC-MS/MS: An Application to Method Development and Validation of Erlotinib in Human Plasma

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