近红外透射光谱法快速无损定量分析甲磺酸加替沙星注射液中的主成分

The Rapid Non-destructive Quantitative Analysis of Essential Component in Gatifloxacin Mesylate Injection by Near Infrared Transmission Spectrometry

目的 :应用近红外透射光谱法快速、无损、定量分析甲磺酸加替沙星注射液中的主成分甲磺酸加替沙星。方法 :用偏最小二乘法建立近红外光谱分析模型 ,交互证实方法确定最佳主成分数 ,所有样本都经紫外分光光度法和高效液相色谱法测定 ,紫外数据用于建模 ,高效液相色谱数据用于与近红外测定结果比较。结果 :无安瓿包装半成品和安瓿包装成品最佳主成分数分别为 3和 4 ,回收率分别为 10 0 %和 99% ,回收率RSD分别为1 6 %和 1 8%。近红外光谱方法与高效液相色谱方法比较 ,测定结果无显著性差异。结论 :近红外透射光谱法是一种快速、简便、无损定量分析方法 ,该方法精密度和准确度都符合要求 ,完全适用于甲磺酸加替沙星注射液半成品和成品中主成分的含量测定。

AIM:To determine essential component(gatifloxacin mesylate)in gatifloxacin mesylate injection by near infrared transmission spectroscopy. METHOD:A mathematical model was developed by partial least square method. The optimal rank was determined by cross validation method. All samples of calibration and prediction set were confirmed by UV and HPLC, and the data by UV was used to develop the mathematical model. RESULT:For non-ampoule-packed samples and ampoule-packed samples , the optimal rank was 3 and 4, respectively; The average recovery of essential component was 100% and 99% , and the RSD was 1.6% and 1.8% respectively. The result of NIR method was compared with that of HPLC and agreed well. CONCLUSION:Results showed that the NIR transmission was rapid, simple, nondestructive and sensitive; and it can be applied to determine the content of essential component in non-ampoule-packed and ampoule-packed gatifloxacin mesylate injection.