Study On Analysis Method And Pharmacokinetics Of Telmisartan Tablet

1. Development of Telmisartan tablets analysis methodA determination method of assay and related substances has been developed, a volume of Shim-pack C₁₈(250mm×4.6mm, 5 μ m) with a mobile phase composed of methal-5mmol·L^-1 potassium dihydrogen phosphate (80:20, v/v) was used in separation. The detection wavelength was 298nm and the flow rate was 1.0mL· min^-1 . Concentration of Telmisartan solution was calculated by external-standard. The result showed that the linear range was from 5.0 to 50.0 u g·mL^-1 (r=0.9999), the speciality and precision of the method was well enough, and the recovery was 101.7%. The assay of 3 batches of Telmisartan tablets measured by the method were 91.0%, 92.4%and 92.3%, respectively. The related substances of telmisartan tablets were quantified by self-compare, the LOD was 1.6ng·mL^-1 . The result indicated that the maximal impurity was not more than 0.15%, the sum of other impurities were not more than 0.43%. The UV-spectrum was used in determination of dissolution of telmisartan tablets, a pH6.8 phosphate buffer of 900mL was introduced to media of dissolution with 75 r·min^-1 . The dissolution of 3 batches of telmisartan tablets measured by the method were more than 80% in 30min.2. The study on pharmacokinetics of telmisartan in Wistar ratA HPLC-fluorescence mathod has been established for determination of telmisartan concentration in plasma and tissues of Wistar rat. A Diamonsil C₁₈ (200mm × 4.6 mm, 5μm) column and a C₁₈ (15mm × 4.6 mm, 10μm) protected column with a mobile phase composed of methal-5mmol·L^-1 potassium dihydrogen phosphate (77:23, v/v) was used in separation. The detection wavelength was λ ex=300nm and λ. em=385nm and the flow rate was 1.0mL· min^-1 . The biological samples were analysed after liquid-liquid extraction , and the concentration of telmisartan was calculated by calibration curve accompanied. The calibration curve of Telmisartan in plasma was linear between 2.0-1000.0 ng · mL^-1 (r = 0.9976), LLOQ was 2.0 ng · mL^-1 . The intra-day precision of QC samples were 6.3%, 4.6% and 2.9%, respectively, the...