Development of validated HPTLC method for densitometric estimation of lacosamide in bulk drug and tablet dosage form

A simple, selective, precise, and reproducible high-performance thin-layer chromatographic (HPTLC) method for the analysis of lacosamide in bulk drug and tablet dosage form was developed. The study was performed on precoated (silica gel aluminium plates 60 F-254). The chromatograms of samples were developed in twin trough glass chamber pre-saturated with mobile phase comprised of toluene: methanol: ammonia (30%) (7.5:2:0.5 v/v/v) at room temperature (25 ± 2°C). The densitometric analysis was carried out in absorbance mode at 258 nm. The optimized mobile phase showed a compact spot of lacosamide (Rf = 0.24 ± 0.02). The linear regression analysis data for the calibration plots showed good linearity (r2 = 0.995) with respect to peak area in the range of 200–2000 ng spot−1. The method was validated as per International Conference on Harmonization (ICH) guidelines. The limits of detection and quantification (50 and 200 ng spot−1 respectively) were also established. The proposed method has shown the excellent recovery (99.65–101.02%) which supports the suitability of the method for the analysis. Statistical analysis of the obtained data showed the selectivity of the proposed method for lacosamide estimation as a bulk drug and tablet dosage form.

Author(s): Pallavi M. Sutar, Deepali A. Bansode and Suneela S. Dhaneshwar

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