Measurement of Moisture Content in Pharmaceutical Tablets by Handheld Near-Infrared Spectrometer: Adopting Quality by...

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Spectroscopy

Background:

• Moisture content control in pharmaceutical solids is critical but challenging.
• Existing methods for moisture determination often require lengthy sample preparation.
• Rapid, in-situ measurement methods are needed for efficient pharmaceutical development and manufacturing.

Purpose of the Study:

• To develop and validate a rapid, non-destructive analytical method for determining moisture content in pharmaceutical tablets.
• To implement near-infrared (NIR) spectroscopy for in-situ moisture measurement.
• To apply Analytical Quality by Design (QbD) principles for method robustness and continuous improvement.

Main Methods:

• Utilized a handheld near-infrared (NIR) spectrometer for quantitative moisture measurement.
• Employed Analytical Quality by Design (QbD) principles throughout method development and validation.
• Validated the method according to International Council for Harmonization (ICH) Q2 guidelines, assessing linearity, range, accuracy, precision, and robustness.
• Estimated limit of detection (LOD) and limit of quantitation (LOQ).

Main Results:

• Developed a rapid and non-destructive NIR spectroscopic method for pharmaceutical tablet moisture analysis.
• Demonstrated the method's suitability for in-situ measurement with minimal sample preparation.
• Successfully validated the method according to ICH Q2 criteria, confirming its reliability and robustness.
• Established LOD and LOQ values for the developed method.

Conclusions:

• The presented NIR spectroscopic method offers a viable solution for rapid, non-destructive moisture determination in pharmaceutical solids.
• The application of QbD principles ensures a robust and continuously improvable analytical procedure.
• The method facilitates efficient quality control and supports a lifecycle approach to analytical method implementation in pharmaceutical manufacturing.