Preparation and Quality Control of Compound Chlorphenamine Maleate and Vitamin Syrup

OBJECTIVE To prepare compound chlorphenamine maleate and vitamin syrup, and establish the method for its quality control. METHODS The syrup was prepared with chlorphenamine maleate and vitamin as chief components. The content of vitamin B1 and nicotinamide were determined by HPLC. The stability of the preparation was investigated as well. RESULTS The preparation was yellow sticky liquid and tasted sweet. Its identification and test conformed to the related standards stated in ChP(2010). The linear ranges of vitamin B1 and nicotinamide were 38.808-194.040 μg·mL^-1 (r=0.999 4), 60.168-300.84 μg·mL^-1 (r=0.999 5); the average recovery was 99.7%, 99.9%, the RSD was 0.89%, 0.78%. After storing for 6 months under room temperature, respectively, no obvious change was noted for the preparation. CONCLUSION The preparation of compound chlorphenamine maleate and vitamin syrup is feasible in technique, stable and controllable in quality.