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目的:建立一种马来酸曲美布汀缓释片释放度的测定方法,以考察其质量。方法:以0.1 mol.L-1盐酸溶液为释放介质,介质量为900 ml,转速为50 r.min-1,采用紫外-可见分光光度法于268 nm波长处测定吸光度。结果:马来酸曲美布汀在4.78～42.98μg.ml-1浓度范围内与其吸光度呈良好的线性关系(r=0.999 8);平均回收率为99.93%,RSD为0.62%;3批样品在2,4,8 h的平均累计释放量分别为34.8%,55.5%,82.6%。结论:该方法操作简单,准确可靠,可作为马来酸曲美布汀缓释片释放度的测定。
Objective: To establish a method for the determination of release of trimebutine maleate sustained-release tablets in order to investigate its quality. Methods: With 0.1 mol·L-1 hydrochloric acid solution as the release medium, the medium volume was 900 ml and the rotation speed was 50 r.min-1. The absorbance was measured at 268 nm by UV-visible spectrophotometry. Results: Trimebutine maleate showed a good linear relationship with its absorbance in the range of 4.78-42.98μg.ml-1 (r = 0.999 8), with an average recovery of 99.93% and a RSD of 0.62%. Three batches of samples The average cumulative release at 2,4,8 h was 34.8%, 55.5% and 82.6% respectively. Conclusion: The method is simple, accurate and reliable, and can be used as the determination of trimebutine maleate sustained release tablets.