Development of Stability Indicating RP-HPLC Method for Tizanidine Hydrochloride in Bulk Drug and Pharmaceutical Dosage Form

The quantitative analysis of tizanidine hydrochloride in both pharmaceutical dosage form and bulk medication has been developed validated using an easy, affordable, quick, unique isocratic HPLC approach. Tizanidine was separated isocratically Waters symmetry C18 ODS as the stationary phase (250×4.6 mm, 5μm particle size), a flow rate 1.0 ml/min, UV detector to track eluate at 230 nm. drug its degradation products could be mobile phase, which made up acetonitrile: phosphate buffer (20:80 v/v) pH-adjusted 3.0 by ortho-phosphoric acid. Linearity, accuracy (recovery), precision, specificity, robustness approach were all validated. For range 4-80 μg/ml, linearity technique satisfactory (correlation coefficient 0.999). Between 100.4 101.3% recovered from medicinal form. In order analyze samples, put under stress conditions, including hydrolysis (acid, base), oxidation, photolysis, heat degradation. forced study demonstrated that it decomposed minimal conditions. Under other scenarios examined, remained steady. It discovered significantly more stable solid state than solution condition. breakdown clearly distinguishable primary peak. validation method may useful for routine drug, respective forms, dissolution studies, stability indicating assay laboratories industries because proves method's power.
 Keywords: RP-HPLC, hydrochloride, Forced degradation, Method