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

(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.

Analysis of Nitrosamines in Processed Meat Products in Medan City by Liquid Chromatography-Mass Spectrometry.

BACKGROUND: Nitrosamine is a carcinogen and the maximum level in processed meat products set by WHO. AIM: The purpose of this study was to determine nitrosamine levels in meat products in Medan City and compared nitrosamine levels with standards set by WHO. METHODS: The samples analysed were obtained from Berastagi Supermarket, sausages, burgers, corned beef and smoked beef. Nitrosamine levels were determined by reverse phase liquid chromatography-mass spectrometry. RESULTS: The results showed that only 5 out of 20 samples of N-nitroso-thiazolidine-4-carboxylic acid (NTCA) nitrosamine ranged from 501.290 to 4227.492 µg/kg. The highest level of NTCA was found in smoked beef (Chiefs), which is 4227.492 µg/kg. N-nitroso-2-methyl-thiazolidine-4-carboxylic acid (NMTCA) was contained in all the samples analysed which ranged from 20.50 to 989.175 µg/kg. The highest NMTCA nitrosamine content was found in smoked beef (Chiefs), which is 989.175 µg/kg. CONCLUSION: From this study reveal that nitrosamines in meat products exceed the maximum standards set by WHO (10 µg/kg).