IR测定复方枸橼酸阿尔维林软胶囊中的西甲硅油

建立红外光谱法测定复方枸橼酸阿尔维林软胶囊中西甲硅油的含量.选用正己烷萃取西甲硅油,根据聚二甲基硅氧烷在1260cm-1波数处Si-CH3基团的对称变形振动有特征吸收峰,使用红外光谱波数为1330-1180cm-1,分辨率:2.0cm-1,狭缝:宽,响应:快;温度:25℃;相对湿度:50％.在选定的分析条件下,系统适用性、精密度和稳定性良好;西甲硅油在1.0-24.0mg·mL-1浓度范围内呈良好线性关系(r=0.9965);加标回收率为100.79％ (RSD=1.68％,n=9); 3批样品含量测定结果分别为标示量的98.70％、97.93％、98.58％.该法简便、快速、专属性强、精密度高,适用于复方枸橼酸阿尔维林软胶囊中西甲硅油的含量测定.

Determination of Simethicone in Compound Alverine Citrate Soft Capsules by IR

The method for the determination of the content of simethicone in compound alverine citrate soft capsules by infrared spectroscopy was established.Simethicone in the drug was extracted by n-hexane,according to the characteristic absorption peak of symmetric deformation vibration for Si—CH₃ group in polydimethylsiloxane at 1260cm^-1 wave number.The determined IR wave number range was from 1330cm^-1 to 1180cm^-1,and the resolution was 2.0 cm^-1,and the selective slit was wide,and the response speed was fast.The setting temperature was 25℃,and relative humidity was 50%.Under the selective analytic conditions,the linear range was 1.0—24.0mg · mL^-1（r=0.9965） and the additional standard recovery was 100.79%with RSD of 1.68%（n=9）.The suitability, precision and stability of system were fine.The contents test results of three batchs sample products were 98.70%,97.93%and 98.58%of the labeled amount.The method is simple and fast with high accuracy and specificity,that can be used to assay the content of simethicone in compound alverine citrate soft capsules.