ABSTRACT
OBJECTIVE: To evaluate the process control capability of lorazepam tablets produced in China. METHODS: Near-infrared spectroscopy combined with cluster analysis(CLA) and principal component analysis(PCA) were used to characterize the different processes and process control space of lorazepam tablets produced in China. Universal quantitative model was built to obtain the content predictions of individual units(tablets), on base of which process mean value,intra-batch and inter-batch differences and distribution status were calculated by univariate statistics analysis methods. RESULTS: Three different manufacturing processes of lorazepam tablets were characterized by both CLA and PCA. The process control spaces reconstructed by the second and third principal components indicated that the process of manufacturer B had smaller variation than that of manufacturer A. The universal quantitative model had a principal component number of 5, r2 square value of 93.89% and bias of -0.008 56. The statistic distribution of API contents showed that 9 batches out of the total 27 batches had relative lager intra-batch differences and manufacturer B had better inter-batch differences than manufacturer A. CONCLUSION: The method this study established can reveal the control levels of different processes of lorazepam tablets, which provide an efficient quality consistency evaluation means for generic drug consistency assessment.