Development and Validation of Stability Indicating High-Performance Liquid Chromatographic Method for Determination of Pramipexole in Solid Dosage Forms.

The Objective Of the current study was to develop a validated stability indicating high performance liquid chromatographic method for Pramipexole in solid dosage form. The method was validated by subjecting the drugs to forced decomposition under hydrolysis, Oxidation, photolysis, and thermal stress conditions prescribed in international Conference on Harmonization. The drug was successfully separated from major and minor degradation products on a reversed –phase Zorbex SB CN column by using Tri Ethyl Amine buffer (PH 7): Methanol (65:35%V/V) as the mobile phase with determination at 263 nm. The flow rate was 1 ml/min. The method was validated with respect to linearity, precision, accuracy, robustness. The response was linear over the range of 2–24 for Pramipexole. The recovery of the drugs from a mixture product was in the range of 99.60–101.84%. The utility of the procedure was verified by its application to marketed formulations that were subjected to accelerated stability studies.