Abstract :
Analytical method development and validation are the continuous and interdependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a vital role in equivalence and risk assessment, management. It helps in establishment of product specific acceptance criteria and stability of results. Validation demonstrates that the analytical procedure is suitable for its intended purpose. Design of experiment is a powerful tool for the method characterization and its validation. Analytical methods for the estimation of rifaximin in bulk and Pharmaceutical dosage forms developed by HPLC, HPTLC and UV visible spectroscopic techniques. The present methods were accomplish the validation parameters according to ICH guidelines like accuracy, precision, linearity, range, robustness, ruggedness, limit of detection and limit of quantitation etc. The published methods were specific, sensitive, reproducible, precise, rapid and simple.
Keyword :
Rifaximin, Literature Survey, Method Development, Validation, ICH Guidelines.