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目的建立测定硫普罗宁注射液含量的近红外光谱(NIR)快速分析方法。方法收集国内7家企业生产的45批硫普罗宁注射液样品,利用高效液相色谱法测定其含量值作为参考值,用光纤探头配合1 mm光程测样配件采集光谱,用偏最小二乘法建立了其近红外透反射定量分析模型。结果所建模型具有较好的预测能力,验证集样品的近红外光谱预测值与真实值间的相关性为99.0%,平均预测偏差为1.30%,预测均方差(RMSEP)为0.982%。结论该法快速、简便,满足药品现场快速检查的需要。
Objective To establish a rapid method for the determination of content of tiopronin by near infrared spectroscopy (NIR). Methods Forty five batches of domestic samples of tiopronin were collected from seven domestic enterprises and their contents were determined by high performance liquid chromatography (HPLC). The spectra were acquired with a fiber optic probe and a 1 mm optical path length measurement kit. Partial least square A quantitative analysis model of near-infrared transmission was established. Results The model had good predictive ability. The correlation between the predicted value and the true value of the sample was 99.0%, the average forecast deviation was 1.30% and the prediction square error (RMSEP) was 0.982%. Conclusion The method is fast and easy to meet the needs of rapid inspection on the drug site.