Research Journal of Science and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

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
     

   Subscribe/Renew Journal


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
Subscription Login to verify subscription
User
Notifications
Font Size


  • Hema, Swati Reddy G. A review on new analytical method development and validation by RP-HPLC. Int Res J Pharm Biosci 2017;4:41-50.

  • Sharma, Shivani, Swapnil Goyal, and Kalindi Chauhan. A review on analytical method development and validation. International Journal of Applied Pharmaceutics (2018): 8-15.

  • Ravisankar P, Navya CN, Pravallika D, Sri DN. A review on step by-step analytical method validation. IOSR J Pharm 2015;5:7-19.

  • Sharp JR. The Problems of Process Validation. Pharm J 1986; 1:43-5.

  • Chauhan A, Mittu B, Chauhan P. Analytical method development and validation: a concise review. J Anal Bioanal Tech 2015;6:1.

  • Committee on Specifications for Pharmaceutical Preparations. Good Manufacturing Practices for Pharmaceutical Products. WHO Technical Report Series no. 82. Geneva: World Health Organization, 1992, pp 14-79.

  • South African Guide to Good Manufacturing Practice. Pretoria: Medicines Control Council, 1996. http://www.pharmanet.co.za/mcc /inpectorate/ins-71998.htm.

  • Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issued for Development and Validation. Washington DC: US Food and Drug Administration, 1994.

  • Agalloco J. Validation: an unconventional review and reinvention, PDA J. Pharm Sci Tech 1995; 49, 175–179.

  • https://www.researchgate.net/publication/322227570_Process_validation_An_essential_process_in_pharmaceutical_industry

  • Md Alamshoaib. Pharmaceutical process validation: an overview. J Adv Pharm Edu Res 2012;2:185-200.

  • Jatto, Elsie, and Augustine O. Okhamafe. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Tropical Journal of Pharmaceutical Research 1.2 (2002): 115-122.

  • FDA Guidance Update: process Validation: General Principles and Practices; version 01; 2009.

  • Guidance on process Validation: Rev 1- EMA/CHMP/CVMP/QWP/7027/2012.

  • Ahir KB, Singh KD, Yadav SP, Patel HS, Poyahari CB. Overview of validation and basic concepts of process validation. Sch Acad J Pharm 2014;3:178-90.

  • Nandhakumar L, Dharmamoorthy G, Rameshkumar S, Chandrasekaran S. An overview of pharmaceutical validation: quality assurance viewpoint. Int J Res Pharm Chem 2011;1:1003-14.

  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonized tripartite guideline Validation of analytical procedures: Text and Methodology Q2 (R1) 6 November 1996.

  • Daksh S, Goyal A, Pandiya CK. Validation of analytical methods–strategy and significance. Int J Res Dev Pharm Life Sci 2015;4:1489-97.

  • Tijare LK, Rangari NT, Mahajan UN. A review on bioanalytical method development and validation. Asian J Pharm Clin Res 2016;9:6-10.

  • Gupta V, Jain AD, Gill NS, Gupta K. Development and validation of HPLC method-a review. Int Res J Pharm Appl Sci 2012;2:17-5.

  • Bose A. HPLC calibration process parameters in terms of system suitability test. Austin Chromatogr 2014;1:4.

  • R Tambe, S Mankar, S Dighe - Analytical Method Development and Validation of Paliperidone: A Review, Research Journal of Science and Technology, 2020, Vol-12, Issue-01,23-35


Abstract Views: 133

PDF Views: 0




  • A Review Article on Analytical Methods Development and Validation

Abstract Views: 133  |  PDF Views: 0

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