Bhoomi D Patel1*, Tanvi A Nayak2, Saiyad Aaftab Hussain Tajmmul Hussain2
1Department of Pharmaceutical Chemistry & Quality Assurance, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA-382260.
2Student, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA-382260.
* Address for Correspondence:
DR. BHOOMI DINESHKUMAR PATEL
Associate Professor & HOD
Department of Pharmaceutical Chemistry & Quality Assurance, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA.
Email: bhoomi.patel@raiuniversity.edu
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.
Keywords Tizanidine HCl, RP-HPLC, Method development and validation, ICH Q2 (R1) guideline
PDF 
Development of RP-HPLC Method of Tizanidine HCL with Some Validation Parameter.pdf