Raju V, Murthy K V R
Division of Pharmaceutical Technology, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530 003, India.
Indian J Pharm Sci. 2011 Sep;73(5):527-36. doi: 10.4103/0250-474X.99000.
The objective of the present study was to develop and validate a discriminative dissolution method for evaluation of carvedilol tablets. Different conditions such as type of dissolution medium, volume of dissolution medium and rotation speed of paddle were evaluated. The best in vitro dissolution profile was obtained using Apparatus II (paddle), 50 rpm, 900 ml of pH 6.8 phosphate buffer as dissolution medium. The drug release was evaluated by high-performance liquid chromatographic method. The dissolution method was validated according to current ICH and FDA guidelines using parameters such as the specificity, accuracy, precision and stability were evaluated and obtained results were within the acceptable range. The comparison of the obtained dissolution profiles of three different products were investigated using ANOVA-based, model-dependent and model-independent methods, results showed that there is significant difference between the products. The dissolution test developed and validated was adequate for its higher discriminative capacity in differentiating the release characteristics of the products tested and could be applied for development and quality control of carvedilol tablets.
本研究的目的是开发并验证一种用于评价卡维地洛片的区分性溶出方法。对不同条件进行了评估，如溶出介质类型、溶出介质体积和桨板转速。使用装置II（桨板）、50转/分钟、900毫升pH 6.8的磷酸盐缓冲液作为溶出介质，获得了最佳的体外溶出曲线。通过高效液相色谱法评估药物释放。根据当前的ICH和FDA指南对溶出方法进行验证，评估了特异性、准确性、精密度和稳定性等参数，获得的结果在可接受范围内。使用基于方差分析、模型依赖和模型独立的方法对三种不同产品获得的溶出曲线进行比较，结果表明产品之间存在显著差异。所开发并验证的溶出试验对于区分所测试产品的释放特性具有较高的区分能力，是足够的，可用于卡维地洛片的研发和质量控制。
