Abstract: Objective To quantitatively analyze the miconazole nitrate suppository by near infrared diffuse reflection spectroscopy technology and chemometrics. Methods 42 batches of miconazole nitrate suppositories from 9 different manufacturers were chosen for analyzing. Firstly, collected the near infrared diffuse reflection spectrum of the samples. Secondly, determined the active pharmaceutical ingredient (API) contents by conventional method. Thirdly, developed the model with the partial least square (PLS) algorithm available in the Quant 2. Results Our model was based on cross validation with API from 7.21% to 19.92% in calibration set. The spectra ranges were 9 994~4 551 cm-1; the pretreatment method was first derivation and vector normalization with smooth points 13; the rank was 7. In the cross validation, the values of R2 and RMSECV were 96.674.04% and 0.50% (mg·mg-1), respectively. Conclusion The method is accurate, quick and convenient, which can be used for quick analysis in drug control.

Key words: miconazole nitrate suppository, near infrared spectroscopy, quick quantitative analysis, chemometrics