Devendra S Mahale
Amit Kumar R. Dhankani
S.P. Pawar
- Student, P.S.G.V.P. Mandal’s College of Pharmacy, Maharashtra, India
- Assistant Professor, P.S.G.V.P. Mandal’s College of Pharmacy, Maharashtra, India
- Principal, P.S.G.V.P. Mandal’s College of Pharmacy, Maharashtra, India
Abstract
The pharmaceutical industry relies on rigorous method validation to ensure the accuracy, precision, and reliability of analytical techniques employed in drug testing and quality control. This comprehensive exploration delves into the validation parameters and guidelines essential for method validation, emphasizing accuracy, precision, linearity, detection and quantitation limits, specificity, range, robustness, and ruggedness. Validation plays a pivotal role in guaranteeing high-quality products, adhering to good manufacturing practices (GMP), and optimizing manufacturing processes. The development of analytical methods for new drugs involves critical considerations, such as the absence of methods in pharmacopeia’s, patent-related constraints, formulation ingredient influences, and the need to measure drug levels or combine drugs effectively. Method development is a crucial precursor to validation, requiring a strategic approach in line with International Conference on Harmonisation (ICH) guidelines and regulatory industry standards. Two analytical methods for vortioxetine are explored in detail: UV Spectrophotometric and High-Performance Liquid Chromatography (HPLC). The UV method involves determining the maximum wavelength, preparing standard stock solutions, dilutions, and analyzing tablet formulations. The HPLC method development encompasses steps such as choosing the procedure, setting up initial conditions, method development, and validation. Several studies exemplify different HPLC approaches for vortioxetine, showcasing their stability-indicating capabilities.
Keywords: Method validation, pharmaceutical analysis, UV spectrophotometry, HPLC, stabilityindicating methods, drug development, regulatory guidelines, GMP, ICH, vortioxetine.
[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production(rrjodfdp)]
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| Volume | 11 |
| Issue | 01 |
| Received | February 16, 2024 |
| Accepted | March 17, 2024 |
| Published | April 18, 2024 |