Development and Validation of HPTLC Method for Estimation of Safinamide Mesylate in Bulk and in Tablet Dosage Form

الملخص EN

A simple, specific, and precise high-performance thin-layer chromatographic method has been developed and validated for estimation of Safinamide Mesylate as bulk and in tablet dosage form.

The chromatographic development was carried out on aluminum plates precoated with silica gel 60 F254 using a mixture of Toluene: Methanol: Triethylamine (4 : 1 : 0.5 v/v) as mobile phase.

Detection was carried out densitometrically at 226 nm.

The RF value of drug was found to be 0.54±0.02.

The method was validated with respect to linearity, accuracy, precision, and robustness.

The calibration curve was found to be linear over a range of 400–2400 ng μL−1.

The % assay (Mean ± S.D.) was found to be 100.27±0.72.

Accuracy of the method was accessed by percentage recovery and found to be 99.77±0.71%.

Thus the proposed HPTLC method was found to provide fast and cost-effective quantitative control for routine analysis of Safinamide mesylate as bulk and in tablet dosage form.