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Devendra S Mahale, Amit Kumar R. Dhankani, S.P. Pawar
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- Student, Assistant Professor, Principal, P.S.G.V.P. Mandal’s College of Pharmacy, P.S.G.V.P. Mandal’s College of Pharmacy, P.S.G.V.P. Mandal’s College of Pharmacy, Maharashtra, Maharashtra, Maharashtra, India, India, India
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Abstract
nThe 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.
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Keywords: Method validation, pharmaceutical analysis, UV spectrophotometry, HPLC, stabilityindicating methods, drug development, regulatory guidelines, GMP, ICH, vortioxetine.
n[if 424 equals=”Regular Issue”][This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production(rrjodfdp)]
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References
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1. Pravallika, K. E.; Ravi, P.; Abboodi, A. H.; Razzaq, A. H.; Sasivardhan, O. Development and Validation of UV Spectrophotometric Methods for the Estimation of Vortioxetine Hydrobromide in Bulk and Pharmaceutical Dosage Forms. Rese. Jour. of Pharm. and Technol. 2017, 10 (11), 3928. https://doi.org/10.5958/0974–360X.2017.00713.2.
2. Santosh Karajgi, Sushma Angadi, Shripad Potadar Quantification of Vortioxetine in Pharmaceutical preparations by validated area under curve UV Spectrophotometric Analytical method Research Journal of Pharmacy and Technology (RJPT)2023; 16(12):5986–5989.
3. Gu, E.; Huang, C.; Liang, B.; Yuan, L.; Lan, T.; Hu, G.; Zhou, H. An UPLC–MS/MS Method for the Quantitation of Vortioxetine in Rat Plasma: Application to a Pharmacokinetic Study. Journal of Chromatography B 2015, 997, 70–74. https://doi.org/10.1016/j.jchromb.2015.05.010.
4. Wróblewski, K.; Szultka-Młyńska, M.; Janiszewska, D.; Petruczynik, A.; Buszewski, B. Development of the Validated Stability-Indicating Method for the Determination of Vortioxetine in Bulk and Pharmaceutical Formulation by HPLC-DAD, Stress Degradation Kinetics Studies and Detection of Degradation Products by LC-ESI-QTOF-MS. Molecules 2022, 27 (6), 1883. https://doi.org/10.3390/molecules27061883.
5. Ravisankar, M.; Alexandar, S.; Kumar, M.; Kumar, R. S.; Venkateswarlu, B. S. Method Development and Validation of Vortioxetine Hydrobromide in Tablet Dosage Form, Indian Journal of Natural Sciences,2021, 12,(67), PP: 32769–32774.
6. Tiris, G.; Alver, C.; Erk, N. A Novel Stability-Indicating Method for Determination of a New Antidepressant Effect of Vortioxetine in a Pharmaceutical Formulation by Using RP-HPLC. Future Journal of PharmaceuticalSciences,2020,6,(118)PP:1–7. https://doi.org/10.1186/s43094–020–00135-w.
7. Rathod, K. G.; Bargaje, G. S.; Rathod, G. R.; Deshpande, O. V. Development and Validation of RP-HPLC Method for Estimation of Vortioxetine in Bulk and Pharmaceutical Dosage Form. International Journal of Trend in Scientific Research and Development 2019, 3 (6), 74–88.
8. Atila Karaca, S.; Rashidova, N.; Uğur, A.; Yeniceli Uğur, D. Development of a Simple HPLC Method for the Quantitation of Vortioxetine in Pharmaceuticals Using DoE Approach. Chem. Pap. 2020, 74 (5), 1541–1549. https://doi.org/10.1007/s11696–019–01008–0.
9. De Diego, M.; Correa, D.; Mennickent, S.; Godoy, R.; Vergara, C. Determination of Vortioxetine and Its Degradation Product in Bulk and Tablets, by LC‐DAD and MS/MS Methods. Biomedical Chromatography 2018, 32 (11), e4340. https://doi.org/10.1002/bmc.4340.
10. Liu, L.; Cao, N.; Ma, X.; Xiong, K.; Sun, L.; Zou, Q.; Yao, L. Stability-Indicating Reversed-Phase HPLC Method Development and Characterization of Impurities in Vortioxetine Utilizing LC–MS, IR and NMR. Journal of Pharmaceutical and Biomedical Analysis 2016, 117, 325–332. https://doi.org/10.1016/j.jpba.2015.08.028.
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Research & Reviews: A Journal of Drug Formulation, Development and Production
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| Volume | 11 | |
| [if 424 equals=”Regular Issue”]Issue[/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] | 01 | |
| Received | February 16, 2024 | |
| Accepted | March 17, 2024 | |
| Published | April 18, 2024 |
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