APPLICATION OF NEAR INFRARED SPECTROSCOPY FOR ENDPOINT DETERMINATION OF BLENDING AND INFLUENCE OF LOADING ORDER
Objective: This study aimed to apply near infrared spectroscopy along with a thief as a tool to determine the endpoint of blending process.
Methods: The calibration model was built by partial least square regression. The model was applied to determine the endpoint, also the effect of loading order on the endpoint for the blending of the formulation containing low concentration of active pharmaceutical ingredient.
Results: The best model had low principal component, low root mean square error of calibration, low root mean square error of prediction and high correlation coefficient. Validation study revealed the measured and the predicted values were non-difference statistically.The model could predict the endpoint of blending process with acceptable precision and accuracy and revealed the order of powder loading slightly affected the blending time.
Conclusion: NIR spectroscopy is the rapid and effective tools that could be applied to study the blending process in the pharmaceutical manufacturing.
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