General approaches to the validation of the pharmacopoeial Dissolution test are considered. The determination of the dissolution validation characteristics (specificity, accuracy, precision, linearity range, and robustness) is described. Specific features for validation of the assay of released drug using UV spectrophotometry and HPLC are described.
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 45, No. 3, pp. 41 – 44, March, 2011.
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Shokhin, I.E., Ramenskaya, G.V. & Davydova, K.S. Modern approaches to the validation of the pharmacopoeial dissolution test. Pharm Chem J 45, 183–186 (2011). https://doi.org/10.1007/s11094-011-0588-9
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DOI: https://doi.org/10.1007/s11094-011-0588-9