NIR对真伪枸橼酸西地那非片快速定性定量分析

Quantitative and qualitative analysis of true or counterfeit Sildenafil Citrate tablets using near infrared spectroscopy

应用近红外光谱技术建立对枸橼酸西地那非片的定量及定性分析方法.通过对162个样品进行近红外光谱分析,分别采用偏最小二乘和第一范围标定法建立定量和定性模型,并将定量分析方法的结果与HPLC定量结果进行比对.所建定量分析模型,主成分数为4,R2为98.91%、RMSECV为1.54.该模型对预示集枸橼酸西地那非的平均回收率为100.14%,近红外光谱分析法处理结果与HPLC法处理结果无显著差异.定性分析模型组间选择性为5.09,对42批真伪样品判错率为0.结果显示,所建立方法可对真伪枸橼酸西地那非片进行快速准确的定性及定量分析.

Quantitative and qualitative analysis of Sildenafil Citrate tablets using near infrared spectroscopy （NIR） was developed. 162 samples were analyzed using near infrared spectroscopy. The mathematical models of quantitative and qualitative analysis were developed by partial least square （PLS） and scaling to first range method, respectively. The quantitative results between HPLC and NIR were compared. The optimal rank of calibration set is 4, the correlation coefficient （R2） of the training set validated by cross-validation is 98.91%, RMSECV is 1.54. The quantitative analysis model was used to determine the samples used for validation, and the average recovery rate of Sildenafil Citrate is 100. 14%. There is no significant difference between NIR and HPLC method. The selectivity between two groups is 5.09,and mistaken judgment rate of 42 samples is 0. The results show that the method established can be applied to quantitative and qualitative analysis of Sildenafil Citrate tablets.