LIQUID CHROMATOGRAPHIC DETERMINATION OF SOLIFENACIN SUCCINATE, FLAVOXATE HYDROCHLORIDE AND TOLTERODINE TARTRATE IN BULK DRUGS AND THEIR PHARMACEUTICAL DOSAGE FORMS
Attia, Ali K.
Frag, Eman Y. Z.
Mohamed, Gehad G.
Ahmed, Heba E.
A simple, precise, specific and accurate reversed phase HPLC (RP-HPLC) method has been developed for the determination of solifenacin succinate (SOLS), flavoxate HCl (FLXHC) and toltoridine tartarate (TOLT) in bulk and pharmaceutical dosage forms. The proposed RP-HPLC method was carried out using Xterra RP-18 column (5 μm practical size, 25 cm x 4.6 mm i.d.). The flow rate, the injection volume and the detection wavelength were 1.0 mL/min, 20 mL and 200 nm, respectively. The mobile phase consisted of 0.05 M pentane sulfonic acid sodium salt (SOLS: pH 3.0±0.05, FLXHC and TOLT: pH 5.5±0.05) and acetonitrile (50:50 v/v). The retention times for SOLS, FLXHC and TOLT drugs were found to be 4.1±0.1 min, 4.3±0.0 min and 5.8±0.1 min, respectively. The calibration was linear over the concentration range of 0.1-100 μg/mL. The mean recoveries for SOLS, FLXHC and TOLT drugs were about 99.80%, 100.43% and 100.00%, respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.