Determination of the Related Substances in Carbidopa and Levodopa Sustained-release Tablets by HPLC
An HPLC method was established for the determination of the related substances in carbidopa and levodopa sustained-release tablets.The Waters X-Bridge C18 column(4.6 mm×250 mm,5 μm)was used,and the analysis was carried out in the gradient elution mode with pH 1.8 phosphate buffer solution as mobile phase A,and pH 1.8 phosphate buffer solution-methanol(250∶750)as mobile phase B.The flow rate was 1.0 mL/min,the detection wavelength was 280 nm,the column temperature was 25 ℃,and the injection volume was 20 μL.The results showed that the main peaks and related substance peaks could be well separated,and it was linear for carbidopa,levodopa,and the seven related substances.The average recoveries(n=9)of seven related substances were 98.97％,100.79％,102.69％,98.13％,102.34％,95.97％,and 100.80％,respectively.The results of the forced degradation tests showed that this method could indicate the degradation products under various conditions.This method has higher specificity,simplicity,and durability than the methods included in the USP 43.It can be used for the production control and stability sample determination of carbidopa and levodopa sustained release tablet.
carbidopa and levodopa sustained-release tabletcarbidopalevodopaHPLCrelated substanceforced degradation
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