Determination of Related Substances in Quetiapine Fumarate Tablets by HPLC
Objective To establish a HPLC method for the determination of related substances in quetiapine fumarate tablets.Methods The impurity content of KL-Imp01,KL-Imp02,KL-Imp03,KL-Imp04,KL-Imp05 in Quetiapine fumarate tablets was determiened by HPLC.An HPLC method was adopted with Techmate C18 column(250 mm4.6 mm5 μm).The mobile phase was methanol-water-triethylamine(phosphoric acid adjusted pH to 8.0)(670:330:4).The flow rate was 1.0 mL/min.The column tem-perature was 40℃.The detection wavelength is 250 nm.The injection volume was 20 μL.Results Under this chromatographic condition,5 impurities(KL-Imp01、KL-Imp02、KL-Imp03、KL-Imp04、KL-Imp05)can be detected at the same time,and each im-purity is well separated from the principal component,and the separation degree is greater than 1.5.The limits of quantitation were 0.1451 μg/mL,0.0388 μg/mL,0.1133 μg/mL,0.0493 μg/mL,0.0510 μg/mL;the limits of detection were 0.0435 μg/mL,0.0117 μg/mL,0.0340 μg/mL,0.0148 μg/mL,0.0153 μg/mL The linear ranges of them were 0.1451～0.9673 μg/mL,0.0388～0.9710 μg/mL,0.1133～0.7554 μg/mL,0.0493～0.8213 μg/mL,0.0510～0.8196 μg/mL.The solution stability of the impurities was good within 48 h,and the RSD of the peak area was less than 2.0%(n=8).The average recovery of low,medium and high recovery solutions was 92.1～108.0%(n=3).Conclusion The method is simple,sensitive,reproducible and durable,and can be used for the quality control of quetiapine fumarate tablets.
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