Liquid chromatographic determination of solifenacin succinate, flavoxate hydrochloride and tolterodine tartrate in bulk drugs and their pharmaceutical dosage forms

• ALI K ATTIA ^[1] ; EMAN Y. Z FRAG ^[2] ; GEHAD G MOHAMED ^[2] ; HEBA E AHMED ^[1]
  1. [1] National Organization for Drug Control and Research

     National Organization for Drug Control and Research

     Egipto

     
  2. [2] Cairo University

     Cairo University

     Egipto

     
• Localización: Journal of the Chilean Chemical Society (Boletín de la Sociedad Chilena de Química), ISSN-e 0717-6309, ISSN 0366-1644, Vol. 61, Nº. 1, 2016, págs. 2772-2776
• Idioma: inglés
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• Resumen

  • A simple, precise, specific and accurate reversed phase HPLC (RP-HPLC) method has been developed for the determination of solifenacin succinate (SOLS), flavoxate HC1 (FLXHC) and toltoridine tartarate (TOLT) in bulk and pharmaceutical dosage forms. The proposed RP-HPLC method was carried out using XterraRP-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 μL/min, 20 μL 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/μL. 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.