拉曼光谱法鉴别盐酸左氧氟沙星注射液的影响因素探究

Study on Influence Factors of Qualitative Identification for Levofloxacin Hydrochloride Injection

目的通过制备不同厂家相同规格的盐酸左氧氟沙星注射液的拉曼光谱图,以经典最小二乘法求得相关系数进行鉴别,探究配方、包装、检测仪器差异这几个因素对鉴别结果的影响。方法分别收集由3个厂家生产,规格为100 mL:200 mg的盐酸左氧氟沙星注射液,扫描获得拉曼光谱图,采用Essential FTIR软件进行基线校正、一阶导数等预处理后建立模型,使用RFDI软件,以经典最小二乘法获得相关系数,进行结果判定。结果相关系数显示配方差异不影响盐酸左氧氟沙星注射液鉴别结果判定,仪器差异对鉴别结果有影响,非PVC共挤膜包装和聚丙烯输液瓶包装对结果判定无影响,玻璃瓶包装会导致结果的误判。结论为保证现场抽检时鉴别结果的准确性,对包装为非PVC共挤膜或聚丙烯输液瓶的样品可进行无损测定,对包装为玻璃瓶的样品应当去包装直接测定,且在抽检之前必须先进行预实验以选择更稳定的拉曼光谱仪。

Objective To explore the effects of the differences of formula, packaging and detecting instruments on the qualitative identification results of Levofloxacin Hydrochloride Injection by preparation of Raman spectra of the products of same specification from different manufacturers and calculation of correlation coefficients using classical least square method. Methods The levofloxacin hydrochloride injections of 100 mL：200 mg from three manufacturers were scanned for Raman spectra, then the models were established after pretreatment of baseline correction and calculation of first-order derivative by Essential FTIR, finally the identification results were judge by the correlation coefficients which were calculated by RFDI with classical least square method. Results The difference of detecting instruments may have influence on the qualitative identification of levofloxacin hydrochloride injection while the difference of formula may have not. Packagings like non-PVC co-extrusion film packaging and polypropylene bottle packaging did not have influence on the final results of qualitative identification while glass bottle packaging would lead to fault. Conclusion To ensure the accuracy of in-situ test, the levofloxacin hydrochloride injections with non-PVC co-extrusion film packaging or polypropylene bottle packaging can be tested directly, while the injections with glass bottle packaging should be tested after the removement of the packaging. And the more stable instruments should be screened through preliminary experiment.