Optimization of determination of pyrazine 2,3-carboxylic acid in dexzopiclone tablets
Objective To optimize the determination of pyrazine-2,3 carboxylic acid in dexzopicone tablets by HPLC and apply the same standard in judging and deduction of pyrazine-2,3 carboxylic acid peaks in dexzopicone tablets from different manufacturers.Methods HPLC was used to screen multiple materials.After determining the source of impurity,we optimized the chromatography conditions,and ultimately used Venusil MP C18 column(4.6 mm×250 mm,5 μm).The mobile phase was water[adjusted to pH(1.5±0.02)with phosphoric acid]as mobile phase A,and methanol as mobile phase B.Gradient elution:0～10 min,3％B;10～16 min,3％～80％B;16～25 min,80％B;and 25.1～35 min,3％B.The flow rate was 1.0 mL·min-1,the detection wavelength was 270 nm,the column temperature was 30 ℃,and the injection volume was 5 μL.Results The linear relationship was good within 0.079 75～15.95 μg·mL-1,with good specificity,repeatability,stability and accuracy.Conclusion The HPLC method can detect pyrazine-2,3 carboxylic acid in dexzopicone tablets with simple operation and accurate results.
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