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Statistical Design for Optimization and Determination of Tizanidine Hcl using Folin-Ciocalteu (Fc) as Chromogenic Reagent

Permender Rathee, Kamal Dua, Sushila Rathee and Vikash Kumar

A simple, sensitive spectrophotometric method has been developed for quantitative determination of Tizanidine
Hydrochloride in bulk and pharmaceutical formulations with application of factorial design. In this method, Tizanidine
Hydrochloride is made to react with Folin-Ciocalteu (FC) reagent under alkaline conditions forming a blue chromogen
having absorption maximum at 663 nm. Beer’s law was obeyed in the concentration range of 4-36 μg/ml. Results
of the analysis were validated as per ICH guidelines and by recovery studies. A 3-factor, 3-level statistical design
(Box-Behnken) was used to derive a second-order polynomial equation to construct contour plots for prediction of
response. Independent variables studied were the FC-reagent (X1), sodium carbonate (X2) and drug concentration
(X3) and the levels of each factor were low, medium, and high. The dependent variable studied was absorbance
(Y1). The aims of this study to determination and optimize the Tizanidine HCl using FC as Chromogenic reagent; the
design demonstrated the role of the derived equation (polynomial) and two dimensional plots in predicting the values
of dependent variable for optimization.