ABSTRACT
OBJECTIVE: To establish a nondestructive and rapid analysis method to measure the critical parameter, mixing uniformity, in the production of Ginkgo leaf dispersible tablets in order to control the quality of products. METHODS: The near-infrared diffuse reflectance spectroscopy (NIRDRS) spectra of the pre-mix and the total mixed Ginkgo leaf dispersible tablets (Wuhan Jianmin Suizhou Pharmaceutical Co., Ltd.) were obtained. The mixing uniformity of samples was monitored by quantitative analysis model and standard deviation method combined with the Mahalanobis distance method, respectively. Meanwhile, lab-made mixing samples and dynamic simulation mixing process were used to validate the feasibility of Mahalanobis distance method. RESULTS: The results obtained from quantitative analysis model and standard deviation method were consistent with each other, and the Mahalanobis distance method was feasible for monitoring the mixing process. CONCLUSION: The method is rapid, simple, and can be used for online and sideline analysis in drug production process.