PMID- 27465975
OWN - NLM
STAT- MEDLINE
DCOM- 20171117
LR  - 20191210
IS  - 1536-3694 (Electronic)
IS  - 0163-4356 (Linking)
VI  - 38
IP  - 5
DP  - 2016 Oct
TI  - A Validated Fluorometric Method for the Rapid Determination of Pregabalin in 
      Human Plasma Applied to Patients With Pain.
PG  - 628-33
LID - 10.1097/FTD.0000000000000325 [doi]
AB  - BACKGROUND: Pregabalin has been used for the treatment of pain. A clinically 
      accepted method applied to patients with pain has not been published for the 
      determination of pregabalin in human plasma. This study developed a fluorometric 
      ultrahigh-performance liquid chromatography (UHPLC) method to measure pregabalin 
      concentration in patients with pain. METHODS: After plasma pretreatment involving 
      protein precipitation, pregabalin and gabapentin as an internal standard were 
      derivatized with 4-fluoro-7-nitrobenzofurazan (NBD-F) under the following 
      reaction conditions: 1 minute, pH 10, and 60 degrees C. The UHPLC separation was 
      performed using a 2.3-mum particle size octadecylsilyl column. The fluorescence 
      detector was set at excitation and emission wavelengths of 470 and 530 nm, 
      respectively. The predose blood samples were collected from 40 patients with pain 
      who have been treated with 75 mg of pregabalin twice daily. RESULTS: The 
      chromatographic run time was 1.25 minutes. No interfering peaks were observed in 
      the blank plasma at the retention times of NBD derivatives. The calibration curve 
      of pregabalin was linear at a range of 0.05-10 mcg/mL (r > 0.999). The lower 
      limit of quantification was 0.05 mcg/mL. The intra-assay accuracy and precision 
      were 98.3%-99.8% and within 4.3%, respectively. The inter-assay accuracy and 
      precision were 103.2%-107.1% and within 4.1%, respectively. The predose plasma 
      concentration of pregabalin in patients with pain ranged from 0.14 to 8.5 mcg/mL. 
      CONCLUSIONS: This study provides a validated fluorometric UHPLC method with fast 
      analytical performance for the determination of pregabalin in human plasma. The 
      present method could be applied to patients with pain and be used for the 
      clinical research or therapeutic drug monitoring of pregabalin.
FAU - Yoshikawa, Nozomi
AU  - Yoshikawa N
AD  - Department of Hospital Pharmacy, Hamamatsu University School of Medicine, 
      Hamamatsu, Shizuoka, Japan.
FAU - Naito, Takafumi
AU  - Naito T
FAU - Yagi, Tatsuya
AU  - Yagi T
FAU - Kawakami, Junichi
AU  - Kawakami J
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Validation Study
PL  - United States
TA  - Ther Drug Monit
JT  - Therapeutic drug monitoring
JID - 7909660
RN  - 0 (Amines)
RN  - 0 (Analgesics)
RN  - 0 (Cyclohexanecarboxylic Acids)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
RN  - 6CW7F3G59X (Gabapentin)
SB  - IM
MH  - Amines/analysis
MH  - Analgesics/analysis
MH  - Chromatography, High Pressure Liquid/methods
MH  - Cyclohexanecarboxylic Acids/analysis
MH  - Data Accuracy
MH  - Fluorometry/*methods
MH  - Gabapentin
MH  - Humans
MH  - Limit of Detection
MH  - Pain/*blood
MH  - Pregabalin/*blood
MH  - Reference Standards
MH  - gamma-Aminobutyric Acid/analysis
EDAT- 2016/07/29 06:00
MHDA- 2017/11/29 06:00
CRDT- 2016/07/29 06:00
PHST- 2016/07/29 06:00 [entrez]
PHST- 2016/07/29 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
AID - 10.1097/FTD.0000000000000325 [doi]
PST - ppublish
SO  - Ther Drug Monit. 2016 Oct;38(5):628-33. doi: 10.1097/FTD.0000000000000325.