摘要

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 mu m 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 mu L 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 mu g/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.

  • 出版日期2016-3