Quantitative Determination of Residual Liquid Paraffin in Microsphere Gel for Injection by Gas Chromatography
Liquid paraffin is a mixture of heavier alkanes extracted from petroleum.It is often used for oil phase preparation of microspheres.However,the internal use of liquid paraffin may have an impact on human health.In order to detect the residual liquid paraffin in microsphere gel simply and quickly,the extraction method was optimized,and the residual liquid paraffin in microsphere gel was detected by gas chromatography flame ion detector(GC-FID).The optimum extraction conditions of liquid paraffin in gel were determined by orthogonal test.The microsphere gel sample was rectified with a rope extractor and petroleum ether at 50 ℃ for 3 h,and then the liquid paraffin in the gel was extracted with 0.4 mol/L potassium hydroxide methanol solution and n-hexane.Filter the upper liquid using a 0.22 μm filter membrane.Detection using HP-5 chromatography column(30 m× 0.320 m×0.25 μm).Standard product preparation 0,10,30,80,90,100 μg/mL.The standard and sample have good peak separation,and the standard curve R2＞0.99.The detection limit and quantification limit are 2.71 and 8.21 μg/mL,respectively.Within 24 h,the content of liquid paraffin in the sample was relatively stable.The recovery rate of sample spiking is between 85.21％and 92.10％,and the relative standard deviation is between 0.94％and 3.31％.The method is simple and rapid,and can be used to quantitatively detect the residual liquid paraffin in gel.
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