Determination of the Enantiomers in Acetylcysteine Effervescent Tablets by HPLC
To establish a method for the determination of enantiomers in acetylcysteine effervescent tablets.The CHIRALPAK AY-H(250 mm×4.6 mm,5 μm)chiral column was used.Mobile phase was n-hexane-absolute ethanol-trifluoroacetic acid(90∶10∶0.1)with equal elution.The column temperature was 20℃.The flow rate was 1.0 mL·min-1.The detection wavelength is 216 nm.Under the selected conditions of liquid chromatography,the peaks of acetylcysteine and enantiomers were separated well,and the excipients did not interfere with the detection of enantiomers.The limit of detection was 12.7 ng.The RSD of 12 samples was 1.9%.The concentration of enantiomers showed a good linear relationship with the peak area in the range of 1.4879 μg·mL-1 to 8.9272 μg·mL-1(r=0.9999).Slightly changed the chromatographic conditions,such as flow rate,column temperature and mobile phase ratio,had no effect on the detection results.The method has strong specificity,high sensitivity,high precision and good robustness,and can be used for the determination of enantiomers in acetylcysteine effervescent tablets.
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