Review on method development and validation for different pharmaceutical dosage form
1 Department of Quality Assurance, P. R. Pote Patil College of Pharmacy, Amravati, India.
2 Department of Pharmacology, P. Wadhwani College of Pharmacy, Yavatmal, India.
3 Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, India.
Review Article
GSC Biological and Pharmaceutical Sciences, 2024, 26(03), 055–067.
Article DOI: 10.30574/gscbps.2024.26.3.0070
Publication history:
Received on 07 January 2024; revised on 19 February 2024; accepted on 22 February 2024
Abstract:
Pharmaceutical analysis is crucial for bulk and formulation quality control. Due to global medication manufacturing and pharmaceutical sector expansion, innovative analytical methods are in demand. Developing analytical procedures is now the most significant part of analysis. Improvements in analytical instruments have led to new analytical methods. The improvement of analytical methodologies and technologies has reduced analysis time, increased precision and accuracy, and decreased analysis costs. As a consequence, the majority of pharmaceutical businesses are investing heavily in specialist analysis labs. Analytical techniques for active pharmaceutical ingredients (API), excipients, drug products, degradation products and related substances, residual solvents, and other chemicals are created and verified. As a consequence, it has become an essential component of the regulating organization's standards. Development of analytical methodologies leads to official test methods. Quality control labs utilize these methods to verify drug identity, purity, safety, effectiveness, and performance. Production analytical methods are becoming relevant to regulators. Regulatory agencies expect applicants to demonstrate control of the drug development process using established analytical methodologies.
Keywords:
Analytical method development; Validation; Quality control; pharmaceutical dosage form
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