Development of a Process Analytical Technology(PAT) method using near-infrared spectroscopy system for evaluating an active coating process for a low-dose drug


The purpose of the present study was to develop a near-infrared spectroscopy (NIRS) method to quickly, accurately, and precisely evaluate and control the coating process of the low dose drug, glimepiride on tablet. For this purpose, a calibration set for the drug was quantified using a partial least-squares regression method with a high-performance liquid chromatography (HPLC) as the reference method. The correlation coefficient (R2) between the NIRS method and the HPLC method in the calibration set was 0.987 and the calibration equation was y = 0.974x + 1.621. The calibration equation was used as an in-process control method during the coating process, and its adequacy was verified. The test results for each validation item indicated no significant differences between reference values (HPLC method) and NIRS method values. The validity of the NIRS method was verified for linearity, accuracy, precision, and robustness for its limited use in controlling a glimepiride coating process. In conclusion, the present study confirmed that the NIRS method rapidly analyzed the amount of the drug substance coated on the tablets and accurately controlled the amount of drug used in the coating process.