Xây dựng và thẩm định phương pháp định lượng đồng thời Clorhexidin và chất bảo quản Nipazol trong nước súc miệng bằng sắc ký lỏng hiệu năng cao

Abstract

This study has developed a method for simultaneous quantification of chlorhexidine and nipazole in oral rinse by reversed-phase HPLC. The method was performed on a C18 column (4.6 mm x 250 mm, 5 µm), using a mobile phase of a mixture of phosphate buffer pH 3.0 – acetonitrile with a gradient program. The injection volume was 50 µL. The UV detector was set at 256 nm. The developed method was validated for the requirements of specificity, system suitability, linearity, accuracy, precision (repeatability and intermediate precision) of both active ingredients and limit of quantification (LOQ) of nipazole according to ICH guidelines-(Q2R2). The validation results indicated that the developed procedure is suitable for the simultaneous quantification of chlorhexidine and nipazole in the oral rinse under study and can be applied in the laboratory.