Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets

Abstract

(1) Background: The functional groups present in tranexamic acid allow direct infrared detection analysis. This study aimed to develop, apply, and validate an infrared spectrophotometry method used for qualitative and quantitative analyses of tranexamic acid in marketed tablets. (2) Methods: This was a descriptive observational study that consisted of several stages: determining the specific wavenumber for analysis, obtaining a simple linear regression equation, analyzing tranexamic acid both qualitatively and quantitatively, and validating the developed method for routine analysis. (3) Results: The peak analysis obtained a range of baseline wavenumbers from 1679.17 to 1295.25 cm−1. The regression equation obtained was Y = 310.8527 × X + 0.9718, and the coefficient of determination (R2) obtained was 0.9994. The tranexamic acids in marketed tablets overall have a similarity index value of more than 0.90 and overall have levels ranging between 97.0% and 103.0%. The infrared spectrophotometry method that was successfully developed, applied, and validated for qualitative and quantitative analyses of tranexamic acid in marketed tablets meets the requirements both qualitatively and quantitatively of the tablet monograph. (4) Conclusions: The infrared spectrophotometry method has been validated and meets the requirements for accuracy, precision, detection limit, quantitation limit, linearity, range, and specificity.

Keywords

• validation
• infrared spectrophotometry
• qualitative
• quantitative
• tranexamic acid