Uniformity Study of Felodipine Sustained-release Tablets by NIRS / 中国药师

ABSTRACT

Objective:To develop the uniformity models for felodipine sustalned-release tablets from 3 manufacturers by NIRS in order to study the difference in the preparation technology and detect and screen the tablets quickly by the robust, accurate and repre-sentative models. Methods:The uniformity models for the tablets from 3 manufacturers among 6 manufacturers with evaluative casual inspection were established by NIRS. Region 4 000-9 000 cm-1 was chosen as the modeling section, and the first derivative plus vector normalization was used as the preprocessing method. Results:The uniformity models for the tablets from the three manufacturers was established and used to predict the samplings from the six manufacturers. The prediction success rate was 100%. Conclusion: NIRS can be used to identify felodipine sustalned-release tablets from different manufacturers quickly and study the preparation technology.