Improvement of Method for Determination of Optical Isomer in Dexzopiclone Tablets
Objective:To improve the HPLC method for the determination of optical isomers in dexzopiclone tablets.Methods:CHIRALCELOD-RH(250 mm×4.6 mm,5 μm)chromatographic column was used,the mobile phase was 0.01 mol/L dibasic sodium phosphate solution(pH adjusted to 5.6 with phosphoric acid)-acetonitrile(57∶43),the flow rate was 0.5 mL/min,the column temperature was 30℃,the detection wavelength was 305 nm,and the injection volume was 20 μL.Results:There was no interference in negative samples,the peak separation degree of each component in the system suitability solution meets the requirements,the optical isomer concentration in the range of 0.3133 μg/mL～10.0248 μg/mL had a good linear relationship with the peak area(r=0.9999),and the dexzopiclone concentration in the range of 0.3138 μg/mL～10.0416 μg/mL had a good linear relationship with the peak area(r=0.9999),the average recovery of optical isomer was 101.4%(RSD=0.75%,n=9),and that of dexzopiclone was 99.2%(RSD=1.90%,n=9),Stable within 8h at room temperature,repeatability,precision and durability are good.Conclusion:The improved method can effectively separate the optical isomers from adjacent impurities in the dexzopiclone tablets and improve the accuracy of the measurement results.
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