• Shivani Sharma Department of Pharmaceutical Quality Assurance, Mandsaur University, Mandsaur (M.P.), India
  • Swapnil Goyal Deparment of Pharmacology, Mandsaur University, Mandsaur (M.P.), India
  • Kalindi Chauhan Department of Pharmaceutics, Mandsaur University, Mandsaur (M.P.), India




Validation, Method development, Limit of quantitation, Limit of detection, Linearity, Robustness, Ruggedness


The top objective of any pharmaceutical industry is to produce products of necessary characteristic and quality reliably, in a cost-effective manner. Development of a method is essential for discovery, development, and evaluation of medicines in the pharmaceutical formulation. The main aim of this review article was to check the development and validation of the procedure employed for the medication from the starting of the formulation to the complete commercial batch of product. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associated samples, it is necessary that the outcomes are reliable. In the pharma industry, validation policy is documented for how to perform validation, types of validation and validation policy are complied with the necessities of good manufacturing practice (GMP) regulations. Validation is very important for the effective running of the pharmaceutical firms. At every stage from raw material to the finished, stability, everywhere validation was performed. The method was developed properly, and validation parameters are explained in terms of accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing with the example of certain drugs. All validation parameters are used in the routine and stability analysis.


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How to Cite

Sharma, S., Goyal, S., & Chauhan, K. (2018). A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION. International Journal of Applied Pharmaceutics, 10(6), 8–15. https://doi.org/10.22159/ijap.2018v10i6.28279



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