SIMULTANEOUS METHOD DEVELOPMENT AND VALIDATION OF GABAPENTIN AND CARBAMAZEPINE IN RAT PLASMA USING LC-MS/MS AND ITS APPLICATION TO PHARMACOKINETIC STUDIES

Objective: For the bioanalytical method of gabapentin and carbamazepine using tiagabine as the internal standard (IS), a simple, rapid, accurate, specific, and repeatable Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) approach was devised. Methods: A Symmetry C18 column (150x4.6 mm, 3.5µ) and mobile phase of 0.1% formic acid in water and acetonitrile (70:30, v/v) are used in this article to summarise the latest advancements in bioanalytical LC-MS/MS procedures. Results: Analysis was carried out within 7 minutes over a good linear concentration range from 6.0ng/mL to 240ng/mL (r2 = 0.9999 ± 0.004) for Gabapentin and 2ng/mL to 80ng/mL (r2 =0.9998± 0.003) for Carbamazepine. Accuracy, precision, recovery, matrix effect and stability results were found to be within the suitable limits. Conclusion: When used successfully for the examination of rat pharmacokinetic studies, the application indicates that all system appropriateness, specificity, linearity, and accuracy metrics are in excellent compliance with USFDA requirements.