ESTIMATION OF GABAPENTIN IN HUMAN PLASMA USING LC-MS/MS METHOD
Abstract
Objective: The objective of this research was to develop and validate a simple, sensitive and specific Liquid Chromatography–Tandem Mass Spectrometry (LC–MS/MS) quantification of Gabapentin in human plasma. The analytical method consists of liquid-liquid extraction of plasma sample followed by the determination of Gabapentin by a LC–MS/MS.
Method: The analyte was separated on a Zorbax Eclipse XDB -C18 (150 x 4.6 mm, 5 µ) column with an isocratic mobile phase of Methanol: Water (50: 50 v/v, pH of 3.0) at a flow rate of 0.8 mL/min. Protonated ions formed by a turbo ionspray in a positive mode was used to detect analyte and internal standard (IS). The MS/MS detection was made by monitoring the fragmentation of m/z 172.20→154.20 for Gabapentin and m/z 176.40→158.10 for internal standard on a mass spectrometer.
Results: The method was validated over the concentration range of 51.356 ng/mL to 8217.008 ng/mL for Gabapentin in human plasma with correlation coefficient greater than 0.98.
Conclusion: The developed method was successfully applied for analyzing Gabapentin in plasma samples for a bioequivalence study with healthy volunteers.
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Key words: Gabapentin; Validation; Analysis; Bioavailability; LC-MS/MS.
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Guidance for Industry, Bioanalytical Method validation, CDER, May 2001
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