Green Alternative in Drug Quality Control Analysis by DoE Optimization: H2 Receptor Antagonists
Year: 2026
Type: article
Abstract: H2 receptor antagonists are often preferred in gastroesophageal reflux disease or in the treatment of gastric acidity disorders. In this study, an HPLC method for simultaneous analysis of H2 receptor antagonists, famotidine, nizatidine, ranitidine, and cimetidine active ingredients was developed by implementing green analytical chemistry principles and a chemometric approach. Chromatographic parameters such as ethanol ratio, buffer concentration, flow rate of mobile phase, and column temperature were optimized by the analysis method. This green HPLC method's system compatibility tests, specificity, sensitivity, linearity, accuracy, precision, recovery, stability, robustness, and consistency parameters were validated to analyze famotidine from the pharmaceutical preparation. The linearity range was 1.5-75 µg/mL, the limit of detection (LOD) was 0.5 µg/mL, and the limit of quantification (LOQ) was 1.5 µg/mL. Afterward, the method specified in the Famotidine tablet USP monograph was validated by examining the same parameters. The linearity range of this method was 5.0-500 µg/mL, the limit of detection (LOD) was 2.0 µg/mL, and the limit of quantification (LOQ) was 5.0 µg/mL. Cimetidine was chosen as the internal standard (IS) in both methods, and the performance of the methods with and without IS was compared. Validation results showed that all were sensitive, precise, accurate, specific, robust and consistent. In addition, validated methods were successfully applied to analyze the famotidine-containing pharmaceutical preparation. No statistically significant difference was found between the results when compared. It has been observed that the developed methods with and without IS are more sensitive than the method specified in the USP monograph, and at the same time, the damage to the environment and human health is minimal.
Source: Cumhuriyet Science Journal
DOI: 10.17776/csj.1959298
Institution: Hacettepe University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
Funder: Hacettepe Üniversitesi
OpenAlex ID: W4401578504