ABSTRACT

A reverse phase HPLC has been developed and validated for estimation of Tizanidine in Human plasma. In this method, a reverse phase column Agilent – C18 Plasma 5 ?m (4.6× 250 mm) as a Stationary phase, with a Mobile Phase of Methanol and 0.05% ortho phosphoric acid in water (pH 2.7) in the ratio of (20:80) at 0.7 mL/min flow rate was used with a DAD detection was carried out at 227nm. The volume injected was 20 µL. The described HPLC method was linear over a concentration range of 10-50µg/ml. Clonidine was used as an internal standard. The Tizanidine showed retention time 4.347 min & Clonidine showed retention time 11.459 min respectively. The developed bioanalytical method was found to be linear in concentration range of 10-50 µg/ml (R2 = 0.999). The stability of the drug spiked human during three freeze thaw cycles was stable in plasma for about one month when stored at frozen state. Conclusions: It can be concluded that the developed bioanalytical method is capable of quantifying Tizanidine from spiked human plasma samples. The method meets the requirements of the ICH Guidelines and can be applied to Bioavailability or Bioequivalence studies of Tizanidine. Keywords: Bio-analytical method, RP-HPLC, DAD, Validation, Tizanidine
Publication date: 25/01/2022

https://ijbpas.com/pdf/2022/January/MS_IJBPAS_2022_JAN_SPCL_2_2025.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.1.2025