Xây dựng và thẩm định qui trình định lượng đồng thời desloratadin và chất bảo quản natri benzoat trong siro ho nghiên cứu bằng kỹ thuật sắc ký lỏng pha đảo

Tóm tắt

A Reversed-phase HPLC method for simultaneous determination of desloratadine and sodium benzoate in cough syrup was introduced. The method was carried out on a C18 column (4.6 mm × 250 mm, 5 mm), using an acetonitrile – phosphate buffer pH 3.0 mixture with composition varying following a gradient program as mobile phase. The mobile phase flow rate was maintained at 1.0 mL per minute. Injection volume was 50 µL. The UV detector was set at 274 nm. The developed method has been illustrated to statisfied the requirements of specificity, system suitability, linearity, accuracy, precision (repeatjability and intermediate precision) according to ICH-(Q2R1) guideline. The validation results indecated that the developed procedure was suitable for simultaneous determination of desloratadine anf sodium benzoate in studied cough syrup, and which would be a potential procedure to applied for other similar syrup matrix.