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Areport on forced degradation studies of artesunate and amodiquine tablets

Manisha Phadke, Vivek K.Jadhav, Datta Patil, R.K.Jadhav

The forced degradation of drug product will evaluate the acceptability of analytical method by establishing the specificity of the method by studying acid hydrolysis, base hydrolysis and oxidation. The objective of the current study was to develop a validated stability-indicating assay method (SIAM) for artesunate and amodiaquine tablets in the fixed dosage form after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis and thermal stress conditions. Resolution of drug and the degradation products formed under different stress studies were successfully achieved on a base deactivated C-18, 10 cmï‚´ 4.6-mminternal diameter, 3- micron particle size HPLC column with mobile phase composed of buffer, (1.36 gmofmonobasic potassiumphosphate in 1000ml of water.Adjust pH to 3.0 with OrthophosphoricAcid.) andAcetonitrile in the ratio 500:400 , a flow rate of 0.80 mL/min (run time of 20 minutes), a column temperature Ambient and an injection volume of 20micro L. Detection of artesunate was byUV detector at a wavelength of 210 nmand 300nmforAmodiaquine.