Comparison of in vitro Dissolution between Generic and Original Furosemide Tablets by Fiber-Optic Method / 中国药师

ABSTRACT

Objective:To establish a real time dissolution determination method for furosemide tablets and compare the similarity of dissolution curves of furosemide tablets from 11 generic drug manufacturers and the original research drug manufacturer in four kinds of dissolution media to evaluate the overall situation of dissolution process of furosemide tablets in our country. Methods:A fiber-optic medicine dissolution process real time test system was used to monitor the dissolution process of furosemide tablets from 11 generic drug manufacturers and the original research drug manufacturer. A paddle method was applied and the rotation speed was 50 r·min-1 . The dissolution medium was pH 1. 2 hydrochloric acid solution, pH 4. 0 acetate buffer, pH 6. 8 phosphate buffer and water, respectively with volume of 900 ml. The absorbance wavelength was 277 nm. The dissolution profile was drawn and f 2 factor was used to evaluate the similarity. Results:The dissolution tests were not influenced by the excipients and the dissolution media. The liner range of furose-mide was 4. 44-26. 66 μg·ml-1(r=0. 9997). The average recovery of furosemide was 101. 26% and RSD was 1. 84%(n=9). Ee-spect to 11 manufactures, there was only one of the dissolution similarity can meet the requirements. Conclusion:A simple, fast and accurate fiber-optic method for medicine dissolution process real time test is established. The method can reflect the real dissolution and provide the information on how to improve the preparation technology and monitor the stability of the preparation technology.