Validation of a dissolution method with HPLC analysis for lasofoxifene tartrate low dose tablets
| Autor: | Monica L Dumont, Hong Jiang, Alex M. Opio, Beverly Nickerson, J. Sean Space, Mark R. Berry |
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| Rok vydání: | 2007 |
| Předmět: |
Pyrrolidines
Time Factors Tetrahydronaphthalenes Chemistry Pharmaceutical Clinical Biochemistry Pharmaceutical Science Sensitivity and Specificity High-performance liquid chromatography Dosage form Analytical Chemistry Estrogen Receptor Modulators Robustness (computer science) Drug Discovery Technology Pharmaceutical Dissolution Chromatography High Pressure Liquid Spectroscopy Hplc analysis Chromatography Dose-Response Relationship Drug Molecular Structure Statistical design Chemistry Low dose Reproducibility of Results Solubility Lasofoxifene Tartrate Tablets |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 44:1064-1071 |
| ISSN: | 0731-7085 |
| DOI: | 10.1016/j.jpba.2007.04.032 |
| Popis: | A dissolution method with high performance liquid chromatography (HPLC) analysis was validated for an immediate release low dose tablet formulation. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, precision, linearity, accuracy and range. Validation of precision included an intermediate precision study using an experimental design in order to satisfy Japanese regulatory requirements. In addition, filter suitability, standard and sample solution stability and method robustness were demonstrated. A statistical design of experiments was used for the robustness evaluation of both the dissolution method and the HPLC analysis method. All results were acceptable and confirmed that the method is suitable for its intended use. |
| Databáze: | OpenAIRE |
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