Content uniformity of pharmaceutical solid dosage forms using Vis-NIR spectroscopy

Importance of the topic

Pharmaceutical content uniformity is a critical quality parameter that ensures each dosage unit contains the intended amount of active pharmaceutical ingredient (API). Traditional methods such as HPLC involve time-consuming dissolution steps and high solvent consumption, resulting in significant operational costs and lengthy analysis times.

Objectives and study overview

This study demonstrates the application of visible and near-infrared (Vis-NIR) spectroscopy to assess content uniformity of ceftazidime tablets. It aims to develop quantitative NIR methods for the API and key excipients using a representative sample set for calibration and validation.

Methodology

A total of 38 ceftazidime tablets were analyzed. Reflectance spectra were acquired over 400–2500 nm using the NIRS XDS RapidContent Analyzer. Data pretreatment included second derivative transformation and selection of specific spectral regions. Partial least squares (PLS) regression models were built and evaluated by cross-validation and external validation.

Instrumentation

• NIRS XDS RapidContent Analyzer
• NIRS XDS iris
• Vision Air 2.0 Pharma Complete software

Main results and discussion

The NIR models exhibited strong agreement with reference HPLC data. For ceftazidime content, R2 was 0.984 with a prediction error (SEP) of 2.1%. Excipient models also showed high R2 values (e.g., starch R2=0.944, SEP=1.7%; sodium carbonate R2=0.966, SEP=2.4%). These figures of merit are comparable to or better than the error range of the reference methods.

Benefits and practical applications

Vis-NIR spectroscopy enables rapid (<1 minute per tablet), non-destructive analysis without solvents or sample preparation, reducing both analysis time by up to 30 hours per batch and laboratory running costs. The approach supports offline and potential inline quality control in pharmaceutical production.

Future trends and possible applications

Integration of NIR spectroscopy into process analytical technology (PAT) frameworks is expected to grow. Method adaptation to other solid and liquid dosage forms and expansion to multicomponent analysis will further enhance real-time quality monitoring capabilities.

Conclusion

Vis-NIR spectroscopy offers a viable alternative to traditional HPLC for content uniformity testing, delivering comparable accuracy with significant time and cost advantages. Continued development may expand its adoption across diverse pharmaceutical formulations.