High-Performance Liquid Chromatographic Technique For Evaluating Solifenacin Succinate Incorporated Into Overactive Bladder Syndrome Treatment

The detection of solifenacin succinate was successfully achieved by developing and validating a new, isocratic, rapid, specific, sensitive reversed phase high-performance liquid chromatographic (RP-HPLC) method. A stationary phase of the HiQ Sil C18 (250 x 4.6 mm) column with a temperature of 25oC was used to quantify solifenacin succinate. The mobile phase ACN: Methanol (85.5:14.5 v/v) at a flow rate of 0.7 mL/min was selected to produce the chromatographic separation of solifenacin succinate, and a photodiode array (PDA) detector operating at 221 nm was used for detection. The linear regression analysis results for plotting the calibration curve showed a good linear relation with r2 = 0.999 with the concentration range of 10–60 µg mL−1. 6.15μg mL−1 was the limit of quantitation (LOQ) and 2.02 μg mL−1 was the limit of detection (LOD). The developed technique was determined to comply with ICH guidelines for parameters like specificity, linearity, precision, accuracy, limit of detection, and limit of quantification.