Development of RP-HPLC Method of Tizanidine HCL with Some Validation Parameter.

Bhoomi D Patel, Tanvi A Nayak, Saiyad Aaftab Hussain Tajmmul Hussain
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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.

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建立盐酸替扎尼定的 RP-HPLC 方法及一些验证参数
本研究汇编了有关盐酸替扎尼定分析方法开发的信息,这将有助于进一步开展有关该药物及其杂质的研究工作。本文献调查提供了有关盐酸替扎尼定单独使用或与其他药物一起使用的分析方法的信息,如 UV、TLC、RP-HPLC、HPTLC、UHPLC 和其他方法。对已发表数据的分析表明,仅有紫外光谱法(校准曲线法)用于盐酸替扎尼定固定剂量复方制剂的估算。盐酸替扎尼定固定剂量复方制剂的高效液相色谱法: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:1.0 ml/min,波长:318 nm。通过评估验证参数,对优化后的 HPLC 条件进行了验证,结果符合 ICH 规定的验收标准。结果表明该方法线性、精确。验证后的 RP-HPLC-PDA 方法可用于盐酸替扎尼定片剂的常规分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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53
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