[Research progress on method validation of near infrared spectroscopy in quantitative analysis]

Area of Science:

• Analytical Chemistry
• Pharmaceutical Science

Background:

• Near-infrared (NIR) spectroscopy is favored in pharmaceuticals for its speed, noninvasive nature, and minimal sample preparation.
• NIR spectroscopy provides valuable chemical and physical information, making it suitable for various pharmaceutical applications.
• Method validation is crucial for established analytical techniques before routine use.

Purpose of the Study:

• To review the progress in validating Near-infrared (NIR) spectroscopy methods for pharmaceutical applications.
• To concentrate on standard documents and key concepts in NIR method validation.
• To offer references for the standardized application of NIR spectroscopy in the pharmaceutical industry.

Main Methods:

• Literature review of validation approaches for NIR quantification models.
• Analysis of standard documents and guidelines related to analytical method validation.
• Focus on experimental standards and decision rules for NIR method validation.

Main Results:

• Current literature shows varied approaches to validating NIR quantification models.
• There is a lack of detailed experimental standards and decision rules for NIR method validation.
• Progress has been made in understanding the validation requirements for pharmaceutical NIR applications.

Conclusions:

• Standardized validation is essential for the reliable application of NIR spectroscopy in the pharmaceutical industry.
• Further development of experimental standards and decision rules is needed for NIR method validation.
• This review provides a foundation for harmonizing NIR method validation practices in pharmaceuticals.