复方硫酸庆大霉素滴鼻剂的制备与质量控制

Preparation and Quality Control of Compound Gentamycin Sulphate Nasal Drops

目的 :不经分离直接测定制剂中硫酸庆大霉素、盐酸麻黄碱、地塞米松磷酸钠3组分含量。方法 :利用Hantzsh反应使庆大霉素形成二氢砒啶衍生物 ,在紫外330nm波长处测定其含量 ;应用双波长原理 ,分别在紫外测定波长256.5nm、241.6nm ,参比波长228.4nm、266.4nm处测定盐酸麻黄碱、磷酸地塞米松含量。结果 :硫酸庆大霉素、盐酸麻黄碱、地塞米松磷酸钠3组分平均回收率分别为 (100.74±0.2) %、(100.15±0.66) %、(99.46±0.35) % ,n=5。结论 :方法简便、快速、准确、稳定 ,适用于该制剂的快速质量控制。

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.