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目的建立甲磺酸伊马替尼片溶出度测定方法。方法以0.1 mo L·L-1盐酸溶液为溶出介质,桨法,转速50 r·min-1,采用紫外分光光度法在波长264 nm处测定吸光度并计算溶出度。结果甲磺酸伊马替在2.22~15.54 mg·L-1浓度范围内线性关系良好,A=0.051 9C+0.003 6(r=0.999 9,n=7);平均回收率100.04%;样品溶出度批内及批间均一性良好。结论该方法快速简便,能用于甲磺酸伊马替尼片的溶出度测定。
Objective To establish a method for the determination of imatinib mesylate dissolution. Methods 0.1 mol L · L hydrochloric acid solution was used as dissolution medium, paddle method and rotation speed was 50 r · min-1. The absorbance was measured at 264 nm by UV spectrophotometry and the dissolution was calculated. Results The imatinib mesylate showed good linearity in the concentration range of 2.22-15.54 mg · L-1, with an average recovery of 100.04% (A = 0.051 9C + 0.003 6, r = 0.999 9, n = 7) Intra-and inter-batch uniformity is good. Conclusion The method is rapid and simple and can be used to determine the dissolution of imatinib mesylate tablets.