Development of a comprehensive near infrared spectroscopy calibration model for rapid measurements of moisture content in multiple pharmaceutical products

• A comprehensive NIR calibration model for moisture measurements.
• Robust and accurate for drug products containing different active ingredients.
• Readily updated to expand applicability to new products.
• Method highly attractive for moisture measurement of hygroscopic materials.
• Could be adopted as a general method for rapid and reliable moisture analysis.

Near infrared (NIR) spectroscopy has been widely used for the determination of water content in a wide variety of samples. With few exceptions, all methods employ a calibration model developed and applicable for a single product. The current study describes a NIR method using a single, comprehensive calibration model to predict the water content in tablets containing different active pharmaceutical ingredients (API). The calibration model was developed for water content range of 2–13% (w/w) using tablets containing three different APIs and different formulation compositions. To develop a robust comprehensive model, individual calibration models were sequentially developed starting from a simple model for one product to including tablets from all three projects in the final model using partial least square analysis method. Data pretreatments and spectral region selections were performed during the method development to optimize the number of factors and the correlation coefficients for cross-validation and prediction by the comprehensive model. The model reliably predicted the water content in tablet samples of these three products, and can be updated for water measurements of new drug products by adding to the model two samples of the new product for calibration purpose.

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