Derivative Spectrophotometric Methods for Determination of Solifenacin Succinate in Bulk and in Tablet Formulation.

Rapid, sensitive, reproducible, and cost-effective zero-order and first-order derivative spectrophotometric method has been developed for the quantification of solifenacin succinate in bulk and its tablet formulation. Preliminary spectrophotometric determination of the drug was carried out in 0.1 N HCl, methanol, and in phosphate buffer pH 2.0 with a total of thirty-three parametric variations. The selected method with three parametric variations employing peak–zero (P–0) and peak–peak (P–P) techniques was assessed for stability, indicating a potential for force-degraded solutions. The method was validated in accordance with the ICH guidelines with respect to linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. Excellent linearity was noted in a concentration range of 1.0–80.0 μg/mL for all three method variants. Limits of detection for the proposed method ranged from 0.03–0.16 μg/mL and limits of quantitation were found to be in the range of 0.09–0.48 μg/mL, respectively. Excellent recovery of the drug was obtained from its marketed tablet formulation with the proposed method. [ABSTRACT FROM AUTHOR]