RÉSUMÉ
Objective To establish a method for determining the dissolution oftorasemide sustained-release tablet in vitro and study the methodology of the determination.The consistency of the in vitro release behavior between self-prepared torasemide sustained-release tablet and original preparation were evaluated by constructed method.Methods HPLC method was applied to detect the cumulative release percentage of self-prepared torasemide sustained-release tablet and original preparation in five kinds of release media (water,0.1 mol/L hydrochloric acid solution,pH 4.5 acetate buffer,pH 6.8 phosphate buffer,and 0.1 mol/L hydrochloric acid solution turn to pH 6.8 phosphate buffer).Similarity factor (f2) was used to evaluate the similarity of release curves.Results There was a good linear relationship between the quality concentration of torasemide and peak area in the range of 1.0-12.0 μg/mL (r =0.9995).Results of precision and stability tests were good,and the RSDs for probational liquid were all lower than 2.0％.The average recovery of accuracy test was 100.04％,and RSD was 0.54％ (n =12).The homogeneity of within group of self-prepared preparation met the technical requirement,RSDs of each sampling points in six Dissolution Vessels were lower than 10.0％.The f2 factors of self-prepared torasemide sustained-release tablet and original preparation were 72,60,77,66,and 60 in five kinds of release media.Conclusion The method in the paper is suitable for the release test of torasemide,meanwhile,the self-prepared tablet shows consistent in vitro release behavior with that of the original preparation.
RÉSUMÉ
Objective To establish a method for the determination of 8 heavy metal elements of Pb,Cd,As,Hg,Co,V,Se,Mo in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Method Through selection of detection wavelengths,optimization of instrument parameters,verification of matrix effect interference and investigation of internal standard for correction of matrix effect interference,the 8 heavy metal elements were analyzed by ICP-OES.Results The recovery rate of the detected elements were increased from 83％-90％ to 94％-100％,after correction of matrix effect interference by internal standard method.The accuracy of the method were good.The spiked recoveries of the detected elements were from 94.3％ to 101.5％.The precision of the method were good (RSD ＜ 3.5％,n =6).The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.22 to 8.54 ng/mL.The quantization limits were from 0.68 to 25.73 ng/mL.Conclusion The established method was accurate,sensitivity,rapid and reliable,which can be applied to the determination of contents of 8 heavy metal elements in iron dextran.
RÉSUMÉ
Objective To establish a method for the determination of 8 heavy metal elements of Pb,Cd,As,Hg,Co,V,Se,Mo in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Method Through selection of detection wavelengths,optimization of instrument parameters,verification of matrix effect interference and investigation of internal standard for correction of matrix effect interference,the 8 heavy metal elements were analyzed by ICP-OES.Results The recovery rate of the detected elements were increased from 83％-90％ to 94％-100％,after correction of matrix effect interference by internal standard method.The accuracy of the method were good.The spiked recoveries of the detected elements were from 94.3％ to 101.5％.The precision of the method were good (RSD ＜ 3.5％,n =6).The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.22 to 8.54 ng/mL.The quantization limits were from 0.68 to 25.73 ng/mL.Conclusion The established method was accurate,sensitivity,rapid and reliable,which can be applied to the determination of contents of 8 heavy metal elements in iron dextran.