Determination of Related Substances of Paliperidone Palmitate Raw Material by HPLC
Objective:To establish a HPLC method for determination of related substances in paliperidone palmitate.Methods:An Inert Sustain C18 column(4.6 mm×150 mm,5 μm)is adopted.The mobile phase A is 0.01 mol/L ammonium acetate solution(pH is adjusted to 9.0)and the mobile phase B is methanol-acetonitrile(the ratio is 10 to 90)with a gradient elution.The column temperature is 25℃and the detection wavelength is set at 280 nm.Results:The separation degree between main peak and adjacent impurities,as well as known impurities,is greater than 1.5;the calibration curves of nine known impurities are linear in the self-concentration range(r＞0.9900).Conclusion:The method is specific and accurate,which can be used for quality control of this product.
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