Validation of high performance liquid chromatography mass spectrometric method in negative ion mode for the estimation of Amlopdipine in human plasma using Amlopdipine D3 as internal standard

Abstract

Pharmaceutical analysis plays a very prominent role in quality assurance as well as quality control of bulk drugs and pharmaceutical formulations. Rapid increase in pharmaceutical industries and production of drug in various parts of the world has brought a rise in demand for new analytical techniques in the pharmaceutical industries. As a consequence, 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. As a consequence, 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 products and related substances, residual solvents, etc. As a result, it has become an integral part of the requirements of the regulatory organization. Analytical method development finally results in official test methods. These methods are used in quality control laboratories to ensure the identity, purity, safety, efficacy and performance of drug products. Regulatory authorities are placing greater emphasis on analytical methods in manufacturing. Drug approval by regulatory authorities requires the applicant to prove control of the entire process of drug development by using validated analytical methods.