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1.
Drug Evaluation Research ; (6): 164-168, 2017.
Artículo en Chino | WPRIM | ID: wpr-515138

RESUMEN

Objective To compare the dissolution curves of reference preparation and self-prepared Iloperidone Tablets in four different pH dissolution media (0.1 mol/L HC1 solution,pH 4.5 acetate buffer solution,pH 6.8 phosphate buffer solution,and water).Methods The solubility of Iloperidone in different pH solutions was measured,the dissolution curves of two preparations in four different pH dissolution media were determined by HPLC,and the similarity was investigated according to the f2 factor method.Results The f2 factors between reference preparation and self-prepared Iloperidone Tablets in four different media were more than 50.Conclusion The two preparations are equivalent in four different pH dissolution media in vitro.

2.
Drug Evaluation Research ; (6): 335-340, 2017.
Artículo en Chino | WPRIM | ID: wpr-513529

RESUMEN

Objective To establish a method for the determination of eight heavy metal elements (Pb,Cd,As,Hg,Co,V,Se,and Mo) in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Methods Through detection wavelength selection,optimization of instrument parameters and applying interference element correction (IEC) method to correction of spectral interference,the eight heavy metal elements were analyzed by ICP-OES.Results The elements recoveries were from 88.7% to 101.3% by correction of spectral interference with IEC method.The accuracy of the method was good.The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.12 to 7.26 ng/rnL.The quantization limits were from 0.40 to 23.96 ng/mL.The precision of the method was good (RSD<3.5%,n=6).Conclusion The results of the spectral interference correction by IEC method are greatly superior to the results of conventional method.The established method is accurate,sensitive,and rapid,which can be applied to the determination of contents of eight heavy metal elements in iron dextran.

3.
Drug Evaluation Research ; (6): 506-512, 2017.
Artículo en Chino | WPRIM | ID: wpr-619509

RESUMEN

Objective To establish a method for the determination of eight heavy metal elements ofPb,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,correction of spectral interference,verification of ionization interference and investigation of suppression methods,the eight heavy metal elements were analyzed by ICP-OES.Results The recovery rate of the detected elements increased 5% to 10% by suppression of ionization interference.The accuracy of the method was good.The spiked recovery rates of the detected elements were from 95.7% to 101.1%.The precision of the method were good (RSD < 3.6%,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 0.15 to 8.09 ng/mL.The quantization limits were from 0.46 to 24.26 ng/mL.Conclusion The method was accurate,sensitivity,rapid and reliable,which can be applied to the determination of contents of eight heavy metal elements in iron dextran.

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