Department of Pharmaceutical Chemistry & Quality Assurance, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA-382260.
Student, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA-382260.
Zhongguo Ying Yong Sheng Li Xue Za Zhi. 2024 Jul 9;40:e20240007. doi: 10.62958/j.cjap.2024.007.
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 (250mm4mm5µm), 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.
本研究汇集了盐酸替扎尼定分析方法开发的信息，这将有助于进一步研究该药物及其杂质。目前的文献调查提供了有关分析方法的信息，如 UV、TLC、RP-HPLC、HPTLC、UHPLC 等方法已分别和其他药物一起被报道用于盐酸替扎尼定药物的分析。对已发表数据的分析表明，仅报道了一种用于测定盐酸替扎尼定固定剂量组合的紫外光谱法（校准曲线法）。采用卓越的反相高效液相色谱法（RP-HPLC）对盐酸替扎尼定进行估计，即流动相-乙腈：磷酸盐缓冲液（pH：7.5）（50：50%v/v），C18 柱（250mm4mm5µm），流速-1.0ml/min，波长：318nm。通过评估验证参数对优化后的 HPLC 条件进行了验证，符合 ICH 设定的验收标准。结果表明该方法具有良好的线性和精密度。经验证的 RP-HPLC-PDA 方法可用于片剂中盐酸替扎尼定的常规分析。
