METHOD DEVELOPMENT AND VALIDATION FOR ESOMPRAZOLE SODIUM INJECTION BY RP-HPLC

Abhishek Kumar , Dr. Nitendra Sahu , Dr.A. Balasubramaniuim , Anamika , Kumari Snehlata

Analytical method validation, Esomprazole sodium injection

For manufacturing systems to be accurate, safe, and reliable, validation and verification are essential stages in the design to operation process. Manufacturing systems are becoming more sophisticated and flexible, and development cycles are getting shorter due to the advancement of intelligent manufacturing technologies and the quickening of market changes. These improve Verification and Validation's thoroughness, effectiveness, and automation needs. In order to guarantee accuracy, safety, and dependability, verification and validation are essential phases in the manufacturing system design and operation process. The complexity and flexibility of manufacturing systems are increasing, and development cycles are getting shorter, due to the advancement of intelligent manufacturing technologies and the quickening of market changes. These improve . validation and verification comprehensiveness, efficiency, and automation requirements. However, the combined benefits of analytical and simulation methods cannot be effectively utilised by current verification and validation systems and instances. Complying with the efficient . validation and verification needs of sophisticated intelligent production systems is challenging.. A manufacturing system based on modular configuration is suggested in this study. framework for verification and validation that combines simulation and analysis techniques for quick results. Manufacturing system validation and verification. The process of building modular manufacturing system configurations is investigated. Asset Administration Shells (AAS) have been used to modularly package and integrate the modular configuration, which has been separated into component function, system logic, and joint model sub-configurations. A quick. Verification and Validation process for manufacturing systems has been established. This process employs a test-module-driven approach to achieve configuration-based . testing of manufacturing systems. It supports synchronized co-simulation with equipment, software, and models in the loop. Finally, a simple manufacturing system. validation and verification case was provided as an implementation reference. The proposed framework can demonstrate the rapid. validation and verification of intelligent manufacturing systems and contribute to the development of automated. validation and verification tools.

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"METHOD DEVELOPMENT AND VALIDATION FOR ESOMPRAZOLE SODIUM INJECTION BY RP-HPLC", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.10, Issue 11, page no.b102-b159, November-2025, Available :https://ijsdr.org/papers/IJSDRTH01014.pdf

Volume 10 Issue 11, November-2025

Pages : b102-b159

Paper Reg. ID: IJSDR_305319

Published Paper Id: IJSDRTH01014

Downloads: 00053

Research Area: Pharmacy All

Country: Vaishali, Bihar, India

Published Paper PDF: https://ijsdr.org/papers/IJSDRTH01014

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDRTH01014

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

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