A Validated Fluorometric Method for the Rapid Determination of Pregabalin in Human Plasma Applied to Patients With Pain
Autor: | Tatsuya Yagi, Junichi Kawakami, Nozomi Yoshikawa, Takafumi Naito |
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Rok vydání: | 2016 |
Předmět: |
Accuracy and precision
Cyclohexanecarboxylic Acids Gabapentin Calibration curve Pregabalin Pain 030226 pharmacology & pharmacy 01 natural sciences 03 medical and health sciences 0302 clinical medicine Limit of Detection medicine Humans Protein precipitation Fluorometry Pharmacology (medical) Amines Chromatography High Pressure Liquid gamma-Aminobutyric Acid Pharmacology Detection limit Analgesics Chromatography medicine.diagnostic_test Chemistry 010401 analytical chemistry Reference Standards Data Accuracy 0104 chemical sciences Therapeutic drug monitoring Human plasma Anesthesia medicine.drug |
Zdroj: | Therapeutic Drug Monitoring. 38:628-633 |
ISSN: | 0163-4356 |
Popis: | 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°C. The UHPLC separation was performed using a 2.3-μm 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. |
Databáze: | OpenAIRE |
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