近红外光谱法快速分析罗红霉素片的含量

目的：建立测定罗红霉素片含量的近红外光谱(NIR)快速分析方法。方法：以全国不同企业生产的罗红霉素片为分析对象．用光纤探头测定近红外漫反射光谱；定量模型的预处理方法为一阶导数与矢量归一化，波长范围9048．7—6098cm^-1，回归方法为最小二乘法。定性鉴别方法为马氏距离与限定值相比较。结果定量模型的浓度范围为19．5％-70．8％，相对标准偏差小于6％：定性鉴别方法可将罗红霉素片与其他抗生素片剂及安慰剂相区别。结论：该法快速、简便，具有一定的专属性，可用于药品的快速检验。

Development of a Near IR Method for Rapid Determination of Roxithromycin Tabletes

Objective: NIR method was developed for rapid determination of roxithromycin tablets. Methods: The diffuse reflectance near - infrared spectra of roxithromycin tablets from different pharmaceutical factories in various locations in this country,were determined by a fibre optic probe. For quantitative analysis,the first derivative combining vector normalization method was used for pre - treatment of the spectra, the wavelength rang of 9048. 7 - 6098 cm-1 was selected to set up the calibration curve by the Partial Least -squares Regression(PLSR)method. Comparing the Mahalanbis Distance with the limit value,roxithromycin tablets were identified. Results;For the quantitative determination,the concent rang was 19. 5% -70. 8% ,the RSD was less than 6%. The qualitative method has a good specificity to distinguish roxithromycin tablets from the other antibiotic tablets and placebo. Conclusion: The method is simple, rapid, and can be applied to drug rapid determination.