Xây dựng và thẩm định phương pháp xác định hoạt tính bromelain theo đơn vị fip trong chế phẩm viên nén bao tan trong ruột

Abstract

Bromelain – a protein disgestive enzyme extracted from pineapple (Ananas comosus.), has many good clinical effect and is safe in use, therefore it is appeared in many drugs and dietary supplements. In this study, we developed a UV – VIS at 275 nm analysis method for Bromelain in a gastro - resistant tablet product. The study optimized and selected the suitable substate, the reaction time of 10 min and the sample concentration of 0.1 FIP Bromelain unit/ml with the reaction condition at 35 ^oC, pH 7.15. The method was validated in specificity, linearity, range, accuracy and precision according to ICH Q2(R1) – 2005 guideline and the bioanalytical method validation guidance. The results showed that the method had liner over the concentration range of 0.05 – 0.15 FIP unit/ml; the accuracy was within 98.7 % - 104.3 %; the precision had RSD < 5 %. Validation results proved that the established method was suitable for determination of Bromelain in enteric - coated tablet.