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目的:建立复方多潘立酮黏附漂浮片释放度的测定方法,进以控制该控释片的质量。方法:以人工胃液作释放介质,以差示分光光度法测定在300 nm和326 nm两波长下的吸收值。结果:辅料对药物及药物之间测定无干扰。在300 nm处,多潘立酮线性范围为4.91~24.56μg/m L(r=0.9993),平均回收率为100.5%,RSD=0.99%。在326 nm处,维生素VB6线性范围为8.11~40.56μg/m L(r=0.9991),平均回收率为100.5%,RSD=0.79%。结论:差示分光光度法为本制剂提供了简便、快速、准确的检测方法。
OBJECTIVE: To establish a method for the determination of the release of compound domperidone stick floating tablets, to control the quality of the controlled release tablets. Methods: The artificial gastric juice was used as the releasing medium and the absorbance at two wavelengths of 300 nm and 326 nm were determined by differential spectrophotometry. Results: Excipients did not interfere with the determination of drugs and drugs. At 300 nm, the linear range of domperidone was 4.91 ~ 24.56 μg / mL (r = 0.9993). The average recovery was 100.5% and the RSD was 0.99%. At 326 nm, the linear range of vitamin VB6 was 8.11-40.56 μg / mL (r = 0.9991) with an average recovery of 100.5% and RSD of 0.79%. Conclusion: Differential spectrophotometry provides a simple, rapid and accurate method for the preparation.