An HPLC method for the determination of ng mifepristone in human plasma

Guo, Zhiyong; Cheng-ding, Chu; Yin, Guochuan; He, Min; Fu, Keqin; Wu, Jianli

doi:10.1016/j.jchromb.2005.12.019

Cited by 13 publications

(13 citation statements)

References 11 publications

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“…The lowest concentration of both mifepristone and monodemethyl-mifepristone at 120 h after dosing was Table 3. Intra-and inter-batch precision and accuracy data for assays of mifepristone and monodemethyl-mifepristone in human plasma (n = 5) 80 6 ng/mL and the current method was sensitive enough for the determination as compared with the previous HPLC methods (Heikinheimo et al, 1986;He et al, 1989;Guo et al, 2006Guo et al, , 2007aWei et al, 2003).…”

Section: Pharmacokinetic Studymentioning

confidence: 71%

“…The retention times for mifepristone, monodemethyl-mifepristone and the IS were 2.20, 1.82 and 3.37 min, respectively. The method had a very short total run time (4.5 min) for simultaneous determination of RU 486 and RU 42633 compared with the reported HPLC methods (Heikinheimo et al, 1986;Heikinheimo, 1989;He et al, 1989;Shi et al, 1993;Stith and Hussain, 2003;Guo et al, 2006Guo et al, , 2007a.…”

Section: Methods Validationmentioning

confidence: 94%

“…Similar solid phase extraction procedures have been reported to extract the analytes from bio-matrices (Stith and Hussain, 2003;Guo et al, 2006Guo et al, , 2007a. The SPE procedure described by Guo et al was tried during our method development.…”

Section: Methods Developmentmentioning

confidence: 97%

“…Various analytical methods have been reported for the measurement of mifepristone, such as radioimmunoassay (RIA; Wang et al, 1994;Leminen et al, 2003), radioreceptor assay (RRA; Kawai et al, 1987;Földesi et al, 1996) and assays based on high-performance liquid chromatography (HPLC; Heikinheimo et al, 1986;Heikinheimo, 1989;He et al, 1989;Shi et al, 1993;Stith and Husain, 2003; 72 Guo et al, 2006Guo et al, , 2007a. Direct RIA and RRA failed to distinguish the parent mifepristone and its metabolites due to the crossreacting metabolites .…”

Section: Introductionmentioning

confidence: 99%

“…However, the sensitivities of previously reported HPLC methods with a high limit of detection (LOD) of 40 ng/mL (Heikinheimo et al, 1986) and 36 ng/mL (He et al, 1989) were not adequate for determination of mifepristone at lower doses. Recently, an HPLC method with a lower limit of quantification (LLOQ) of 10 ng/mL was reported to determine mifepristone at 0.33-120 h after a single 25 mg dose (Guo et al, 2006). However, it was an external standard method and could not avoid the influence of instrument fluctuation and operation error.…”

Section: Introductionmentioning

confidence: 99%

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Simultaneous determination of mifepristone and monodemethyl‐mifepristone in human plasma by liquid chromatography–tandem mass spectrometry method using levonorgestrel as an internal standard: application to a pharmacokinetic study

Tang

Zhong

et al. 2008

Biomedical Chromatography

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A rapid and sensitive liquid chromatography/tandem mass spectrometry (LC-MS/MS) method was developed and validated to simultaneously determine mifepristone and monodemethyl-mifepristone in human plasma using levonorgestrel as the internal standard (IS). After solid-phase extraction of the plasma samples, mifepristone, monodemethyl-mifepristone and the IS were subjected to LC-MS/MS analysis using electro-spray ionization (ESI) in the multiple reaction monitoring (MRM) mode. Chromatographic separation was performed on an XTERRA MS C(18) column (150 x 2.1 mm i.d., 5 microm). The method had a chromatographic run time of 4.5 min and linear calibration curves over the concentration ranges of 5-2000 ng/mL for mifepristone and monodemethyl-mifepristone. The recoveries of the method were found to be 94.5-103.7% for mifepristone and 70.7-77.3% for monodemethyl-mifepristone. The method had a lower limit of quantification (LLOQ) of 5.0 ng/mL and a lower limit of detection (LOD) of 1.0 ng/mL for both mifepristone and monodemethyl-mifepristone. The intra- and inter-batch precision was less than 15% for all quality control samples at concentrations of 10, 100 and 1000 ng/mL. These results indicate that the method was efficient with a short run time (4.5 min) and acceptable accuracy, precision and sensitivity. The validated LC-MS/MS method was successfully used in a pharmacokinetic study in healthy female volunteers after oral administration of 25 mg mifepristone tablet.

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Section: Pharmacokinetic Studymentioning

confidence: 71%