APPLICATION OF STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR QUANTITATION OF PRAMIPEXOLE IN PHARMACEUTICAL DOSAGE FORM

摘要

A sensitive, selective, precise, and stability-indicating high performance thin layer chromatographic method was developed and validated for the determination of pramipexole both as a bulk drug and in formulation. The method uses aluminum plates precoated with silica gel 60F-254 as the stationary phase and solvent system ethyl acetate: toluene: methanol: ammonia 8:1.5:0.5:0.6, (v/v/v/v). This system gave compact spots for pramipexole (Rf: 0.22 +- 0.02). Pramipexole was subjected to acid and alkali hydrolysis, oxidation, and photodegradation. The peaks of the degradation products were well resolved from that of the pure drug and had significantly different Rf values. Densitometric analysis of pramipexole was performed in the absorbance mode at 263 nm. The linear regression analysis data for the calibration plots showed a good linear relationship over a concentration range of 200–2000 ng x spot~-1. The mean values of the correlation coefficient, slope, and intercept were 0.9986 +- 1.42, 4.1411 +- 0.965, and 768.73 +- 1.24, respectively. The method was validated for precision, robustness, and recovery. The limit of detection and limit of quantitation were 30 and 200 ng x spot~-1, respectively. Statistical analysis showed that the method is repeatable, selective, and can separate the drug from its degradation products and can be used to monitor stability.