Quality control of tablets by Near Infrared (NIR)-Spectroscopy.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Spectroscopy

Background:

• Near-infrared (NIR) spectroscopy is a recognized analytical method for raw material identification and active ingredient quantification in pharmaceuticals.
• Existing methods often face challenges with variations in excipients and appearance among different manufacturers' tablets.

Purpose of the Study:

• To develop and validate calibration models for quantifying active pharmaceutical ingredients (APIs) in tablets using NIR spectroscopy.
• To assess the feasibility of NIR spectroscopy for API quantification independent of tablet origin, excipients, and appearance.
• To investigate the applicability of NIR spectroscopy for analyzing blister-packed pharmaceutical preparations.

Main Methods:

• Development of partial least square (PLS) calibration models using tablets of atenolol, enalapril, and acetylsalicylic acid from various sources.
• Comparison of NIR spectroscopy results with High-Performance Liquid Chromatography (HPLC) for enalapril tablets, adhering to USP 26 standards.
• Evaluation of method accuracy within +/- 10% of the declared API content.

Main Results:

• Successful establishment of calibration models enabling API quantification in tablets irrespective of excipients and visual characteristics.
• Demonstrated accuracy of NIR spectroscopy for determining API concentrations within the specified tolerance limits.
• Confirmed the applicability of NIR spectroscopy for analyzing APIs in blister-packed tablets.

Conclusions:

• NIR spectroscopy provides a robust and versatile method for quantifying active ingredients in diverse pharmaceutical tablets.
• The technique's independence from excipients and appearance makes it a valuable tool for quality control.
• NIR spectroscopy is suitable for analyzing APIs in both loose tablets and those packaged in blisters.