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《Sichuan Journal of Physiological Sciences》 2017-03
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Optimization of determination of the related substances in Resperidone tablets by HPLC

Zhang Yue-yang;Liu Feng;Sichuan Institute for Food and Drug Control;  
Objective:To optimize an HPLC method for the determination of the related substances in Resperidone tablets.Methods:Analysis was carried out on a Sepax GP-C18(4.6×100 mm,3 μm);the column temperature was 35 ℃,the flow rate was 1.0 mL·min~(-1),the mobile phase A is water-methanol-TFA(89:19.5:0.1)(adding ammonia to adjust the pH to 3.0),the mobile phase B is water-methanol-TFA(61:39:0.1)(adding ammonia to adjust the pH to 3.0),the injection volume was 20 μL,and the detection wave length was 275 nm.Results:The linear ranges of Resperidone were 0.5088 μg·ml~(-1)~1017.6 μg·ml~(-1),respectively.The limits of detection(S/N=3)was 0.5088 ng· mL~(-1).Conclusion:The optimized method is more propitious to detect the related substances in Resperidone tablets,and control the known impurities.
【CateGory Index】: O657.72;R927.1
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