Stability-Indicating Method for Determination of Tizanidine Hydrochloride in Pharmaceutical Lc-Cad Method Using Chemometric Approach

Abstract

A new LC method for tizanidine hydrochloride in tablet dosage form using a charged aerosol detector (CAD) is described. The influence of various parameters on chromatographic system was investigated by factorial designs and Derringer's desirability. Chromatographic conditions were: mobile phase constituted of acetonitrile and ammonium acetate buffer 17 mM (60:40; v/v), column oven at 39 °C and flow rate 0.8 mL.min-1 performed in on Acclaim Trinity P1 column UV at 230 nm. Thus, it was possible to validate a simple method to assay the tizanidine and its counter-ion in three formulations (drug reference, generic and manipulated). Method showed specificity when challenged by forced degradation and excipients. Finally, the method was compared with USP monograph method demonstrating equivalence in assay evaluation.

Development and validation of UPLC method for quantitative estimation of related impurities in tizanidine hydrochloride tablets

“…Literature reveals, several analytical methodologies used for the estimation of Tizanidine, either as a single entity or as combined entity with another drug. These methods include spectrophotometric and HPLC methods (Brandalise et al, 2017;Devarajan and Sivasubramanian, 2006;Mantri et al, 2005;Ramaa et al, 2006;Reddy et al, 2008;Samel and Raman, 2009;Subramanian et al, 2004;Vijayakumar et al, 2010). Recent findings have revealed that even significantly low levels of impurities affect the safety as well as the efficacy of a drug product.…”