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目的:建立厄贝沙坦胶囊的溶出度测定方法。方法:照溶出度测定法(《中国药典》2010年版二部附录XC第一法),以0.1 mol·L~(-1)盐酸溶液为溶剂,转速为100 r·min~(-1);紫外分光光度法测定,测定波长为245 nm。结果:30 min内产品的溶出率达到75%以上,辅料对主药测定无干扰,厄贝沙坦线性范围为2.50~25.00μg·ml~(-1)(r=0.999 9),回收率为100.5%(RSD=0.13%,n=9)。结论:本法操作简便、准确可靠,适用于厄贝沙坦胶囊的溶出度测定。
Objective: To establish a method for the determination of dissolution of irbesartan capsules. Methods: According to the method of dissolution determination (the first method of appendix XC of Chinese Pharmacopoeia, 2010 edition), the speed was 100 r · min ~ (-1) with 0.1 mol·L ~ (-1) hydrochloric acid as solvent. UV spectrophotometry, determination of wavelength of 245 nm. Results: The dissolution rate of the product reached more than 75% within 30 min. The excipient did not interfere with the determination of main drug. The linear range of Irbesartan was 2.50 ~ 25.00 μg · ml -1 (r = 0.999 9) 100.5% (RSD = 0.13%, n = 9). Conclusion: This method is simple, accurate and reliable, suitable for the determination of dissolution of irbesartan capsules.