Determination of the related substances in haloperidol decanoate by HPLC

YAN Yao-dong; AI Guo; HUI Jin-ling

Abstract：Objective:To develop an HPLC method for the separation of haloperidol decanoate (HPD) and determination of its known related substances.Methods:The analysis was conducted on an Hypersil GOLD C18 column (150 mm × 4.6 mm,3 μm)with a mobile phase of 17 g·L-1 Tetrabutylammonium Hydrogen Sulfate-acetonitrile by gradient elution at the flow of 1.5 mL· min-1.The column temperature was set at 35 ℃ and the detection wavelength was set at 230 nm.Results:The known impurities and degraded products by forced destruction were completely separated from HPD.The calibration curves of known impurities(A,B,C,D,E,F,G,H,I,G,K and L)were linear in the self-concentration ranges (r ＞ 0.995 0,n =5)and the correction factors were 0.9 ～ 1.1.The average recovery rates (n =9) were 108.1％,104.0％,108.3％,101.2％,108.1％,98.2％,102.2％,93.5％,105.3％,96.7％,113.3％ and 100.3％ respectively,RSD were 2.82％,3.22％,2.30％,5.28％,1.30％,4.54％,7.26％,8.01％,2.76％,2.98％,1.87％ and 6.71％,respectively.The RSD of precision (n =6)of the above compounds were 0.40％,0.55％,0.44％,0.71％,0.60％,0.57％,0.48％,0.47％,0.50％,0.47％,0.57％ and 0.62％,respectively.Conclusion:The established method is specific,accurate and sensitive,which is suitable for the determination of related substances in HPD.