Anumolu P D, Satyanarayana M, Gayatri T, Praveena M, Sunitha G, Subrahmanyam C V S
Gokaraju Rangaraju College of Pharmacy, Osmania University, Hyderabad-500 090, India.
Indian J Pharm Sci. 2016 Jan-Feb;78(1):166-9. doi: 10.4103/0250-474x.180246.
A simple, rapid, specific and highly sensitive spectrofluorimetric method has been developed for the quantification of dabigatran etexilate mesylate in bulk and capsule dosage form. A linear relationship was found between fluorescence intensity and concentration in the range of 0.01-1.0 μg/ml in dimethyl sulphoxide as solvent at an emission wavelength of 391 nm after excitation at 334 nm, with a good correlation coefficient (0.989). The detection and quantification limits were found to be 0.005 and 0.015 μg/ml, respectively. The proposed method was applied for dabigatran etexilate mesylate capsules, results reveal with percentage recovery of 102% and percentage relative standard deviation values were found to be less than 2 for accuracy and precision studies. The proposed method was validated for linearity, range, accuracy, precision, limit of detection and quantification according to International Conference on Harmonization guidelines. Statistical analysis of the results revealed high accuracy and good precision. The suggested procedures could be used for the determination of dabigatran etexilate mesylate in bulk and capsule dosage form in quality control laboratories of industries as well as in academic institutions.
已开发出一种简单、快速、特异且高度灵敏的荧光分光光度法，用于定量测定甲磺酸达比加群酯原料药及胶囊剂型。以二甲亚砜为溶剂，在334 nm激发波长下，于391 nm发射波长处，荧光强度与浓度在0.01 - 1.0 μg/ml范围内呈线性关系，相关系数良好（0.989）。检测限和定量限分别为0.005和0.015 μg/ml。该方法应用于甲磺酸达比加群酯胶囊，准确度和精密度研究结果显示回收率为102%，相对标准偏差百分比值小于2。根据国际协调会议指南，该方法在线性、范围、准确度、精密度、检测限和定量限方面均得到验证。结果的统计分析显示准确度高且精密度良好。所建议的方法可用于工业质量控制实验室以及学术机构中测定甲磺酸达比加群酯原料药及胶囊剂型。
