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A Review Article on Analytical Methods Development and Validation


Affiliations
1 Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal: Rahta, Dist: Ahmednagar 413737, India
     

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Any pharmaceutical industry's primary goal is to consistently produce products with the required characteristics and quality at a reasonable cost. A method must be developed for the discovery, development, and evaluation of medicines in pharmaceutical formulations. The primary goal of this review paper was to examine the creation and validation of the medicine formulation technique from the beginning. applies to the entire commercial batch of the product. When an analytical approach is used to obtain results for the quality of medicine-related samples, it is critical that the results are accurate. A validation policy is specified in the pharmaceutical industry for how to execute validation, types of validation, and validation policies to meet the requirements of good manufacturing practise (GMP) laws. Validation is critical to the efficient operation of pharmaceutical companies. Stability and validation were undertaken at every stage, from raw material to completed product. The method was appropriately established, and validation parameters were discussed using the example of various substances in terms of accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing. For the routine and stability analyses, all validation parameters are utilised.

Keywords

Method development, Validation Parameter, Accuracy, System suitability, LOD, LOQ
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  • A Review Article on Analytical Methods Development and Validation

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Authors

Vishakha Shingote
Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal: Rahta, Dist: Ahmednagar 413737, India
S. D. Mankar
Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal: Rahta, Dist: Ahmednagar 413737, India
S. B. Dighe
Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal: Rahta, Dist: Ahmednagar 413737, India

Abstract


Any pharmaceutical industry's primary goal is to consistently produce products with the required characteristics and quality at a reasonable cost. A method must be developed for the discovery, development, and evaluation of medicines in pharmaceutical formulations. The primary goal of this review paper was to examine the creation and validation of the medicine formulation technique from the beginning. applies to the entire commercial batch of the product. When an analytical approach is used to obtain results for the quality of medicine-related samples, it is critical that the results are accurate. A validation policy is specified in the pharmaceutical industry for how to execute validation, types of validation, and validation policies to meet the requirements of good manufacturing practise (GMP) laws. Validation is critical to the efficient operation of pharmaceutical companies. Stability and validation were undertaken at every stage, from raw material to completed product. The method was appropriately established, and validation parameters were discussed using the example of various substances in terms of accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing. For the routine and stability analyses, all validation parameters are utilised.

Keywords


Method development, Validation Parameter, Accuracy, System suitability, LOD, LOQ

References