Development and Validation of the NP-HPTLC Method for the Estimation of Dimenhydrinate in Bulk and Tablet Formulation

A simple, accurate, and precise High-Performance Thin-Layer Chromatography (HPTLC) method has been developed and validated for the analysis of Dimenhydrinate in bulk and tablet formulations. The chromatographic separation in the normal phase was conducted using a mobile phase consisting of Benzene: Methanol in an 8:2 (v/v) ratio on silica gel 60 F₂₅₄HPTLC plates measuring 10 × 10cm with a thickness of 200 micrometers. Densitometric analysis for Dimenhydrinate was performed at a wavelength of 279nm, resulting in a well-resolved peak at a retention factor (Rf) of 0.47±0.02. The linear concentration range for Dimenhydrinate was determined to be 500–3000ng/band. This developed method was validated according to ICH guidelines for accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), and ruggedness. Linear regression analysis data for the calibration of the HPTLC method demonstrated a strong linear relationship with a regression coefficient (r²) greater than 0.999. The detection limit and quantification limit were established at 5.98 ng/band and 18.12ng/band, respectively. Statistical analysis confirmed the accuracy, precision, and ruggedness of the developed method, making it suitable for the routine analysis of Dimenhydrinate in both bulk and tablet matrices.