Methodology for the validation of analytical methods involved in uniformity of dosage units tests
| Autor: | Roland Djang’eing’a Marini, Ph. Hubert, Bruno Boulanger, E. Rozet, Eric Ziemons |
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| Rok vydání: | 2013 |
| Předmět: |
High probability
Spectroscopy Near-Infrared Design stage Chemistry media_common.quotation_subject Validation Studies as Topic Loratadine Biochemistry Quality by Design Analytical Chemistry Reliability engineering Pharmaceutical Preparations Research Design Sample size determination Sample Size Environmental Chemistry Spectrophotometry Ultraviolet Quality (business) Tolerance interval Chromatography High Pressure Liquid Spectroscopy Tablets media_common |
| Zdroj: | Analytica Chimica Acta. 760:46-52 |
| ISSN: | 0003-2670 |
| DOI: | 10.1016/j.aca.2012.11.013 |
| Popis: | Validation of analytical methods is required prior to their routine use. In addition, the current implementation of the Quality by Design (QbD) framework in the pharmaceutical industries aims at improving the quality of the end products starting from its early design stage. However, no regulatory guideline or none of the published methodologies to assess method validation propose decision methodologies that effectively take into account the final purpose of developed analytical methods. In this work a solution is proposed for the specific case of validating analytical methods involved in the assessment of the content uniformity or uniformity of dosage units of a batch of pharmaceutical drug products as proposed in the European or US pharmacopoeias. This methodology uses statistical tolerance intervals as decision tools. Moreover it adequately defines the Analytical Target Profile of analytical methods in order to obtain analytical methods that allow to make correct decisions about Content uniformity or uniformity of dosage units with high probability. The applicability of the proposed methodology is further illustrated using an HPLC-UV assay as well as a near infra-red spectrophotometric method. |
| Databáze: | OpenAIRE |
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