Saurabh Prakash Andhale (M.Pharm) and Dr. Ravindranath. B. Saudagar (M.Pharm,PhD)


The development of sound Analytical methods is of crucial importance during the process of drug discovery, release to market and development Pharmaceutical analysis plays a very prominent role in quality assurance as well as quality control of bulk drugs and pharmaceutical formulations. Analytical method development has become the basic activity of analysis. Recent development in analytical methods has been resulted from the advancement of analytical instruments. The improvement of the analytical method development and analytical instruments have reduced the time of analysis, increased precision and accuracy and reduced costs of analysis most of pharmaceutical organizations are investing huge amount of money for the establishment of advanced analytical laboratories. Analytical techniques are developed and validated for active pharmaceutical ingredients (API), excipients, drug products, degradation studies and related substances, residual solvents etc. Drug approval by regulatory authorities requires the applicant to prove control of the entire process of drug development by using validated analytical methods. There is a great need for development of new analytical methods for quality evaluation of new emerging drugs. Analytical method development provides a high degree of assurance and is an important process in the drug discovery

Keywords: Analytical method development, validation, Quality control.

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