Validation of an FTIR-ATR Method for Gabapentin Analysis in Capsules
DOI:
10.29303/jbt.v26i3.13076Published:
2026-10-05Downloads
Abstract
Gabapentin analysis in capsule dosage forms requires an analytical procedure capable of providing reliable identification and quantitative performance with relatively simple sample preparation. This study aimed to evaluate the analytical characteristics of an attenuated total reflectance Fourier transform infrared (FTIR-ATR) procedure for gabapentin analysis in capsules. Gabapentin BPFI was prepared at concentrations of 0.4%, 0.6%, 0.8%, 1.0%, and 1.2% using methanol extraction and analyzed directly by FTIR-ATR. Method performance was evaluated based on linearity, precision, accuracy, limit of detection (LOD), limit of quantitation (LOQ), and spectral similarity. The calibration curve produced the regression equation y = 77.244x + 2.7113 with an R² value of 0.9961, indicating a strong linear relationship over the tested concentration range. Precision at 1.0% concentration yielded a relative standard deviation (RSD) of 0.316%, while accuracy showed a mean recovery of 98.58%. The calculated LOD and LOQ were 0.0994% and 0.3013%, respectively. Spectral comparison between the capsule sample and gabapentin BPFI showed a similarity of 78.047%, with characteristic absorption patterns of gabapentin retained in the sample spectrum. These results indicate that the FTIR-ATR procedure demonstrated satisfactory linearity, repeatability, and recovery within the evaluated experimental conditions. However, further evaluation of specificity, independent sample preparation precision, and matrix-based recovery is required before the procedure can be considered fully validated for quantitative quality-control applications.
Keywords:
Analytical validation Capsule matrix FTIR-ATR Gabapentin Spectral similarityReferences
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