甲磺酸伊马替尼片溶出度方法的建立

发布时间：2018-05-05 22:14

本文选题：甲磺酸伊马替尼片 + 溶出度　；参考：《药物分析杂志》2015年11期

【摘要】：目的:建立甲磺酸伊马替尼片溶出度的方法。方法:采用紫外-可见分光光度法进行溶出度测定,检测波长为264 nm。按照中国药典2010版(二部)附录ⅩC第二法(桨法),转速为50 r·min-1,分别以p H 1.0盐酸溶液、p H 4.0醋酸盐缓冲液、p H6.8磷酸盐缓冲液和纯化水4种溶剂为溶出介质,溶出体积为1 000 m L,于不同时间点取样测定溶出曲线,比较4种溶出介质中自制制剂与原研制剂溶出曲线,建立甲磺酸伊马替尼片溶出度的检查方法。结果:在4种溶出介质中,甲磺酸伊马替尼质量浓度在4.8~14.5μg·m L-1范围内与吸光度值呈良好的线性关系(r=0.999),精密度试验的RSD分别为0.04%、0.16%、0.08%、0.07%,稳定性试验的RSD分别为0.11%、0.21%、0.32%、0.26%,平均回收率(n=9)分别为99.8%(RSD=0.33%),99.9%(RSD=0.23%),99.9%(RSD=0.32%),99.9%(RSD=0.28%)。自制制剂与原研制剂在4种溶出介质中15 min内溶出度均在90%以上,两者溶出曲线具有相似性。结论:本法经方法学验证,可用于甲磺酸伊马替尼片剂溶出度的检查。
[Abstract]:Objective: to establish a method for dissolution of imatinib mesylate tablets. Methods: the dissolution was determined by UV-vis spectrophotometry and the detection wavelength was 264 nm. According to appendix X C of Chinese Pharmacopoeia 2010 Edition (part two), the second method (propeller method) with a rotational speed of 50 r min-1 was used as solvent for dissolution with pH 1.0 hydrochloric acid solution, pH 4.0 acetate buffer solution, pH 6.8 phosphate buffer, and purified water, respectively. The dissolution curve was determined by sampling at different time points, and the dissolution curves between the self-made preparation and the original preparation were compared with those of the original preparation. A method for the determination of dissolution of imatinib mesylate tablets was established. Results: there was a good linear relationship between the absorbance of imatinib mesylate and the absorbance in the range of 4.8N 14.5 渭 g m L-1, and the RSD of the precision test was 0.04 0.160.160.88, and the RSD of the stability test was 0.110.210.320.320.26, and the average recovery was 0.330.330.330.330.330.339RSD0.2399.90.999. The dissolution rate of the self-made preparation and the original preparation was above 90% in 15 min in 4 kinds of dissolution media, and the dissolution curve was similar between them. Conclusion: this method can be used to determine the dissolution of imatinib mesylate tablets.
【作者单位】：江苏康缘药业股份有限公司;中药制药过程新技术国家重点实验室;
【分类号】：O657.32;R927

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