茜草双酯片溶出度测定方法学验证.docVIP

茜草双酯片溶出度测定方法学验证[摘要] 目的：对自制茜草双酯片的溶出度检查进行方法学验证，同时与市售产品进行对比研究。方法：根据《中国药典》2005年版二部附录ⅩC第二法对其溶出度进行检查。采用紫外分光光度法，在264 nm波长处测定茜草双酯的吸收度，建立溶出度测定方法，同时进行了方法学验证。结果：采用该方法测定茜草双酯片，以浓度对吸收度进行线性回归，得回归方程为A=0.089 9C-0.002，相关系数为0.995 3。茜草双酯在1.67~8.05 μg/ml范围内浓度与其吸收度呈良好的线性关系。重复性试验的RSD为0.51%；平均回收率为99.97%，RSD为1.04%。结论：经与市售产品比较，我们自制的产品质量与市售产品一致，且溶出度测定方法能有效控制该产品的质量。 [关键词] 茜草双酯片；溶出度测定；方法学研究 [中图分类号]R917 [文献标识码]A [文章编号]1673-7210（2008）05（a）-027-03 Methodological validation of solubility of Rubidatum Tablets PENG Gang1, YANG Wei-quan2, ZENG Fang2, KANG Zhi-ying3 (1.Guangdong Daxiang Pharmacy Co. LTD., Guangzhou 510385,China;2. Huangpu Branch, the First Affiliated Hospital,Sun Yat-sen University, Guangzhou 510700,China;3. Guangzhou Xiangxue Pharmacy Corp.,Guangzhou 510530,China) [Abstract] Objective: To methodologically validate the detection of solubility of self-made Rubidatum Tablets and to make comparision with similar products commercially available. Methods:The detection was carried out following the procedure described in the second method in appendix ⅩC, second part of 2005 edition of Chinese Pharmacopoeia. The solubility of Rubidatum Tablets was detected with ultraviolet spectrophotometry at 264 nm.According to the results ,we established a procedure and validated it methodologically. Results: we performed a linear regression analysis by using the concentration (C) and UV absorption(A) as independent and dependent variables respectively, the regression equation was calculated as A=0.089 9C-0.002, r=0.995 3. Within the concentration range of 1.67~8.05 μg/ml, excellent linear relevance was witnessed between concentration and absorption. RSD of repeatability test was 0.51%;the average recovery was 99.97% with RSD of 1.04%. Conclusion:Comparing with the products commercially available, our product are proved to be of the same quality, while the validation of the detection method is effective. [Key words] Rubidatum Tablets;Solubility detection; Methodological study 茜草双酯片属