Preparation and Quality Control of Compound Gentamycin Sulphate Nasal Drops / 中国药房

ABSTRACT

OBJECTIVE： To determine the gentamycin sulphate,ephedrine hydrochloride and dexamethasone sodium phosphate in nasal drops without need of separation.METHODS： Gentamycin was determined via the dihydrolutidine derivatives produced by Hantzsh reaction using UV-spectrophotometry.The detecting wavelengths was 330nm.A dual-wavelength spectrophotometry was used for determination of ephedrine hydrochloride and dexamethasone sodium phosphate.The detecting wavelengths were 256.5nm and 241.6nm and the reference wavelengths were 228.4nm and 266.4nm for ephedrine hydrochloride and dexamethasone sodium phosphate,respectively.RESULTS： The average recovery rates of gentamycin sulphate,ephedrine hydrochloride and dexamethasone sodium phosphate were 100.74％ (CV=0.2％ ,r=0.9 999,n=5),100.15％ (CV=0.66％ ,r=0.9 997,n=5)and 99.46％ (CV=0.35,r=0.9 996,n=5)respectively.CONCLUSION： This method is simple,rapid,accurate and stable and suitable for rapid quality control of compound gentamycin sulphate nasal drops.