Abstract：
This study compiles the information for the development of analytical methods for estimation of the Tizanidine HCl that will be helpful for further research work on this drug and its impurity. The present Literature survey provides information about the Analytical methods like UV,TLC,RP-HPLC,HPTLC,UHPLC and other methods have been reported for Tizanidine HCl drug individually and along with other drugs. The analysis of published data revealed that, there was only UV spectroscopic method (calibration curve metod) is reported for estimation of Tizanidine HCl fixed dose combination. Estimation of Tizanidine HCl by superlative RP-HPLC method i.e. Mobile phase- Acetonitrile: phosphate buffer (pH: 7.5) (50:50%v/v), Column C18 (250mm*4mm*5µm), Flow rate- 1.0 ml/min, Wavelength: 318 nm. Optimized HPLC condition was validated by assessing validation parameters and it meet the acceptance criteria set by ICH. It was showed method was linear and precise. The validated RP-HPLC-PDA method can be used for routine analysis of Tizanidine HCl in tablet.
摘要：
这项研究为开发用于估算盐酸Tizanidine的分析方法提供了信息，这将有助于对该药物及其杂质的进一步研究工作。本文献调查提供了有关UV，TLC,RP-HPLC,HPTLC,UHPLC和其他方法已经报道了单独的和与其他药物一起的盐酸替扎尼定药物。对公布数据的分析显示，据报道，只有紫外光谱法（校准曲线）用于估算盐酸替扎尼定固定剂量组合。通过最高级RP-HPLC方法，即流动相-乙腈：磷酸盐缓冲液（pH：7.5）（50：50％v/v），色谱柱C18(250mm*4mm*5µm),流速-1.0ml/min,波长：318nm。通过评估验证参数来验证优化的HPLC条件,并且其满足ICH设定的验收标准。结果表明，该方法线性、准确。验证的RP-HPLC-PDA方法可用于片剂中盐酸替扎尼定的常规分析。
