H2 Reseptör Antagonistlerinin Yeşil Hplc Ayırımı İçin Kemometrik Optimizasyon Yaklaşımı ve Famotidin İçeren Farmasötik Preparatlara Uygulanması

Abstract

H2 receptor antagonists are often preferred in gastroesophageal reflux disease or in the treatment of gastric acidity disorders. In this thesis, 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 chemometric approach. Chromatographic parameters such as ethanol ratio, buffer concentration, flow rate of mobile phase and column temperature were optimized the analysis method. System compatibility tests, specificity, sensitivity, linearity, accuracy, precision, recovery, stability, robustness and consistency parameters of this green HPLC method were validated for the analysis of 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. Afterwards, the validation of the method specified in the Famotidine tablet USP monograph was carried out 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 validation results showed that the methods were sensitive, precise, accurate, specific, robust and consistent. These two validated methods were successfully applied to the analysis of the famotidine-containing pharmaceutical preparation. By comparing the results, no statistically significant difference was found between them. It has been observed that the developed method is 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.