Nghiên cứu xây dựng quy trình xác định tạp chất liên quan của mupirocin trong kem thuốc bằng phương pháp HPLC

Abstract

A reverse-phase HPLC method for determination of the constituent compounds in Mupirocin cream was developed: Column - Agilent C8 (25 cm M.6 mm, 5 pm); detector - UV (240 nm); Column temperature - 35 °C; Mobile phase -tetrahydrofuran and pH 5.7 ammonium acetate buffer, gradient elution; Flow rate -1.0 ml/min. The method was validated by the ICH guidelines: The linearity was good at the range of2.1-7.0mg-mL⁻¹ (r > 0.998); RSD of intra-and inter-day precision variations <10.0%. The method proved simple, accurate, suitable for quality control in mupirocin cream.