RESUMO
Objective:To prepare compound Xiaoshangtong spray films and establish an HPLC method for quality control. Meth-ods:Chitosan hydrochloride and PVP as the main film-forming materials, and HPMC as the film-forming assitant agent, the com-pound Xiaoshangtong spray films were prepared. Lidocaine and mupirocin were simultaneously determined by HPLC. A Hypersil ODS2 column(250 mm × 4. 6 mm, 5 μm)was used. The mobile phase was composed of 0. 5% ammonium dihydrogen phosphate-methanol (40∶60, adjusting pH to 6. 0 ± 0. 5 with sodium hydroxide). The flow rate of mobile phase was 1. 0 ml·min-1 and the temperature of the column was 30 ℃. The detection wavelength was 222nm and the injection volume was 20 μl. Results: The linear range of lido-caine was 25. 0-400. 0 μg·ml-1(r=0. 999 7) and the average recovery was 100. 14% (RSD=1. 21%,n=9). The linear range of mupirocin was 25.0-400.0 μg·ml-1(r=0.999 9)and the average recovery was 101.13%(RSD=0.57%,n=9). Conclusion:The preparation process is reasonable. The established determination method is accurate and reliable, and suitable for the quality con-trol of the compound Xiaoshangtong spray films.