PMID- 18495561
OWN - NLM
STAT- MEDLINE
DCOM- 20080818
LR  - 20191210
IS  - 1570-0232 (Print)
IS  - 1570-0232 (Linking)
VI  - 868
IP  - 1-2
DP  - 2008 Jun 1
TI  - Solid-phase extraction and liquid chromatography/tandem mass spectrometry assay 
      for the determination of pitavastatin in human plasma and urine for application 
      to Phase I clinical pharmacokinetic studies.
PG  - 95-101
LID - 10.1016/j.jchromb.2008.04.036 [doi]
AB  - A sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method was 
      developed and evaluated for the determination of pitavastatin in human plasma and 
      urine. Samples were extracted using solid-phase extraction (SPE). The major 
      benefit of the present method was the high sensitivity, with a lower limit of 
      quantification (LLOQ) of 0.08 ng/mL. Pitavastatin and internal standard (IS, 
      rosuvastatin) were separated on a C(18) column with a mobile phase consisted of 
      methanol/water (75:25, v/v) with 0.05% formic acid. Drug and IS were detected by 
      LC/MS/MS with positive electrospray ionization (ESI). Accuracy and precision for 
      the assay were determined by calculating the intra- and inter-batch variation of 
      quality control (QC) samples at three concentration levels, with relative 
      standard deviations (R.S.D.s) of less than 15%. The developed method was 
      successfully applied to determine pitavastatin in human plasma and urine, and was 
      proved to be suitable for use in Phase I clinical pharmacokinetic study after 
      oral administration of pitavastatin (1, 2 and 4 mg) in healthy Chinese 
      volunteers.
FAU - Di, Bin
AU  - Di B
AD  - Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of 
      Education, Nanjing, PR China.
FAU - Su, Meng-Xiang
AU  - Su MX
FAU - Yu, Feng
AU  - Yu F
FAU - Qu, Lan-Jin
AU  - Qu LJ
FAU - Zhao, Li-Ping
AU  - Zhao LP
FAU - Cheng, Ming-Chuan
AU  - Cheng MC
FAU - He, Lei-Ping
AU  - He LP
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Validation Study
DEP - 20080503
PL  - Netherlands
TA  - J Chromatogr B Analyt Technol Biomed Life Sci
JT  - Journal of chromatography. B, Analytical technologies in the biomedical and life 
      sciences
JID - 101139554
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Quinolines)
RN  - M5681Q5F9P (pitavastatin)
SB  - IM
MH  - Adult
MH  - Female
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/blood/*pharmacokinetics/urine
MH  - Male
MH  - Quinolines/blood/*pharmacokinetics/urine
MH  - Reference Standards
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
MH  - Solid Phase Extraction/*methods
MH  - Tandem Mass Spectrometry/*methods
EDAT- 2008/05/23 09:00
MHDA- 2008/08/19 09:00
CRDT- 2008/05/23 09:00
PHST- 2007/10/12 00:00 [received]
PHST- 2008/04/23 00:00 [revised]
PHST- 2008/04/26 00:00 [accepted]
PHST- 2008/05/23 09:00 [pubmed]
PHST- 2008/08/19 09:00 [medline]
PHST- 2008/05/23 09:00 [entrez]
AID - S1570-0232(08)00288-2 [pii]
AID - 10.1016/j.jchromb.2008.04.036 [doi]
PST - ppublish
SO  - J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Jun 1;868(1-2):95-101. doi: 
      10.1016/j.jchromb.2008.04.036. Epub 2008 May 3.