Validação de metodologia analítica por cromatografia líquida para doseamento e estudo da estabilidade de pantoprazol sódico Validation of analytical methodology by hplc for quantification and stability evaluation of sodium pantoprazole

Abstract

Pantoprazole is a proton pump inhibitor used in the treatment of digestive ulcers, gastro-esophageal reflux disease and in the eradication of Helicobacter pylori. In this work, an analytical method was developed and validated for the quantification of sodium pantoprazole by HPLC. The method was specific, linear, precise and exact. In order to verify the stability of pantoprazole during dissolution assays, pantoprazole solution in phosphate buffer pH 7.4 was kept at room temperature and protected from light for 22 days. Pantoprazole presented less than 5% of degradation in 6 hours and the half live of the degradation was 124 h.

Keywords

• pantoprazole
• validation
• stability