A method for the “Dissolution” test was developed and validated for tablets of the new bisphosphonate sodium prodronate and was compliant with the general normative requirements. Dissolution was carried out on an instrument with paddles rotating at a rate of 50 rpm. The quantity of drug entering solution over 45 min was assed by UV spectrophotometry via formation of complexes with copper ions, with an absorption peak at 237 nm.

中文翻译：

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一种新的双膦酸钠丙膦酸钠片剂“溶出度”测试方法的开发和验证

开发并验证了新的双膦酸钠丙膦酸钠片剂的“溶出度”测试方法，该方法符合一般规范要求。溶解是在带有以 50 rpm 速率旋转的桨的仪器上进行的。通过紫外分光光度法测定 45 分钟内进入溶液的药物量，通过与铜离子形成复合物，在 237 nm 处有一个吸收峰。