Abstract
A novel stability-indicating high-performance liquid chromatographic assay method was developed and validated for quantitative determination of pramipexole dihydrochloride in bulk drugs and in pharmaceutical dosage form in the presence of degradation products. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using an Ace5-C18 (250×4.6 mm, 5 µm) advance chromatography column, and 10 mmol L-1 ammonium acetate and acetonitrile (75:25 v/v) as a mobile phase. The detection was carried out at a wavelength of 260 nm. The pramipexole was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Degradation was observed for pramipexole in base, in acid and in 30% H2O2. The drug was found to be stable in the other stress conditions attempted. The degradation products were well resolved from the main peak. The percentage recovery of pramipexole was from (99.87 to 99.98%) in the pharmaceutical dosage form. The developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, specificity and robustness. The forced degradation studies prove the stability indicating power of the method.
Highlights
The primary target in developing this stability indicating high performance liquid chromatography (HPLC) method is to achieve the resolution between pramipexole and its degradation products
To achieve the separation of degradation products we used a stationary phase C-18 and combination of mobile phase 10 mmol L-1 ammonium acetate with acetonitrile
The tailing factor obtained was less than two and retention time was about 3.3 min for the main peak and less than 4 min for the degradation products, which would reduce the total run time and increase the productivity reducing the cost of analysis per sample
Summary
The aim of the present study was to develop and validate a stability-indicating HPLC assay method for pramipexole as bulk drug and in pharmaceutical dosage form as per ICH guidelines.
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