The Analytical Method Development and Validation: A Review

  • Mayuri Doltade Department of Pharmaceutical Quality Assurance, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India
  • Ravindranath Saudagar Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

Abstract

Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. The main purpose of the analytical method development and validation is to prove that proposed analytical method is accurate, specific, precise and robust in the pharmaceutical industry for analysis of a drug moiety. Analytical methodology development has become the essential activity of study. Recent development in analytical methods has been resulted from the advancement of analytical instruments. Analytical techniques are developed and validated for active pharmaceutical ingredients (API), excipients, drug products, degradation products and related substances, residual solvents, etc. Method validation is outlined as the method of proving that an analytical technique is appropriate for the meant use and this is often a very important requirement for analytical purpose. Result from methodology validation is used to decide the quality, reliability and consistency of analytical data. Validation parameters are explained in term of accuracy, precision, linearity, specificity, limit of detection (LOD), limit of quantification (LOQ), ruggedness, robustness and system suitability. This review offers concepts concerning varied strategies to check the stability of drug and varied validation parameters as per varied regulative authorities. The review focused on the concept, criteria, steps, strategy and importance of analytical method development and validation.


Keywords: Analytical Method Development, Method Validation, Strategy, Steps, Need, ICH guidelines.

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Author Biographies

Mayuri Doltade, Department of Pharmaceutical Quality Assurance, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

Department of Pharmaceutical Quality Assurance, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

Ravindranath Saudagar, Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

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How to Cite
Doltade, M., & Saudagar, R. (2019). The Analytical Method Development and Validation: A Review. Journal of Drug Delivery and Therapeutics, 9(3), 563-570. https://doi.org/10.22270/jddt.v9i3.2774