Investigation of the distributional homogeneity on chlorpheniramine maleate tablets using NIR-CI.

Homogeneity is the basic element of pharmaceutical analysis. Distributional Homogeneity Index (DHI) was proposed to assess the distributional homogeneity of commercial chlorpheniramine maleate (CPM) tablets. Furthermore, the divergence value of DHI value from expectation DHI (value = 1) was calculated to obtain the CPM distributional homogeneity. The distribution of commercial CPM tablets from six brands was successfully visualized using near infrared chemical imaging (NIR-CI) coupled with characteristic wavenumber method and binary image. Besides, content homogeneity of CPM was obtained through calculating the proportion of white region in the binary image. The result demonstrated that the distributional homogeneity of brand 4 was to be the best among all the brands, following by brand 2, brand 3, brand 5, brand 6 and brand 1. Furthermore, the sequence of the content uniformity was different from the distributional homogeneity, which demonstrated that content uniformity could not represent the distributional homogeneity. This work was a significant method guideline to assess the distributional homogeneity in pharmaceutical field.