THẨM ĐỊNH PHƯƠNG PHÁP ĐỊNH LƯỢNG SALBUTAMOL SULFAT TRONG PHIM SALBUTAMOL SULFAT GIẢI PHÓNG NHANH BẰNG SẮC KÝ LỎNG HIỆU NĂNG CAO

Abstract

Objective: To validate a method for the quantification of salbutamol sulfate in fast dissolving film by high performance liquid chromatography (HPLC) in order to contribute to product quality standardization. Subjects and methods: Quantitative salbutamol sulfate by HPLC method with GRACE Apollo C18 column (4.6×150 mm, 5µm), column temperature 25°C, flow rate 1 ml/min, detector UV at 276 nm, injection volume 20 µl, mobile phase consisting of sodium dihydrophosphate solution pH 3.1 and methanol (85:15). Results: The method ensured suitability, specificity, linearity, repeatability, and precision as specified by ICH. Conclusion: The quantitative method meets the requirements and can be used for the quantification of salbutamol sulfate in the fast-dissolving film of salbutamol sulfate.