Expeditive Chromatographic Methods for Quantification of Solifenacin Succinate along with its Official Impurity as the Possible Acid Degradation Product.

Abstract

Two selective stability-indicating procedures were adopted for the quantification of Solifenacin succinate (SOL) along with its acid degradant, in its powder form or in pharmaceutical tablet. Under stress conditions, the acid degradation pathway of SOL was investigated, its official impurity (SOL imp-A) was obtained as the possible acid degradation product, also. A densitometric technique based on the separation of SOL from SOL imp-A employing HPTLC plates prelaminated with silica gel 60F254 as the stationary phase and a developing solution containing methanol:chloroform:ammonia (8:1:1, v/v/v) and UV scanning of the developed bands at 220nm. Linear regression analysis data for the calibration plot of SOL showed perfect linear relationships throughout the range of concentration 10-60μg/band. A reversed phase C18 analytical column (4.6 × 250mm, 5μm) was also used to separate the mixture at a flow rate of 1mL/min, using acetonitrile:0.05M phosphate buffer (70:30, v/v) as the mobile phase and phosphoric acid to set pH = 3.5. Quantification was obtained at 220nm using peak area and linear calibration curve across a concentration range of 10-70μg/mL. The recommended procedures were applied to the existing dosage form, and they generated satisfactory results.