Development and Validation of a Stability-Indicating HPTLC Method for Analysis of Rasagiline Mesylate in the Bulk Drug and Tablet Dosage Form

Abstract EN

A simple and sensitive thin-layer chromatographic method has been established for analysis of rasagiline mesylate in pharmaceutical dosage form.

Chromatography on silica gel 60 F254 plates with 6 : 1 : 2(v/v/v) butanol-methanol water as mobile phase furnished compact spots at Rf 0.76±0.01.

Densitometric analysis was performed at 254 nm.

To show the specificity of the method, rasagiline mesylate was subjected to acid, base, neutral hydrolysis, oxidation, photolysis, and thermal decomposition, and the peaks of degradation products were well resolved from that of the pure drug.

Linear regression analysis revealed a good linear relationship between peak area and amount of rasagiline mesylate in the range of 100–350 ng/band.

The minimum amount of rasagiline mesylate that could be authentically detected and quantified was 11.12 and 37.21 ng/band, respectively.

The method was validated, in accordance with ICH guidelines for precision, accuracy, and robustness.

Since the method could effectively separate the drug from its degradation products, it can be regarded as stability indicating.