摘要
目的 :建立了紫外光谱法 (U V)和高效液相色谱法 (HPL C)测定盐酸雷尼替丁氯化钠注射液的含量。方法 :UV法用水作溶剂 ,选择 314± 2 nm作为测定波长 ;HPL C法用 5 0 %甲醇作溶剂 ,以 Alltim a C1 8作为色谱柱 ,0 .1mol/ L 醋酸钠 -甲醇 (32∶6 8)为流动相 ,流速 0 .5 ml/ min,检测波长为 32 0 nm。结果 :UV法盐酸雷尼替丁在 4～ 2 0 μg/ ml之间线性良好 ,相关系数 r=0 .99998,回收率为 99.8% ,RSD=0 .3% (n=5 ) ;HPL C法盐酸雷尼替丁在 10 0～ 30 0 μg/ ml之间线性良好 ,相关系数 r=0 .9998,回收率为 10 0 .8% ,RSD=0 .4 % (n=5 ) ,日内、日间精密度 (RSD)分别为 0 .5 % (n=5 )和 0 .9% (n=4 )。结论 :用上述两法测定本品含量 。
OBJECTIVE:A UV method and a HPLC method were established for the determination of ranitidine hydrochloride and sodium chloride injection. METHOD:The UV method used water as solvent. 314±1nm was selected as determination wavelength. The HPLC method used 50% methanol as solvent. The separation was performed on an analytical C 18 Column. The mobile phase was 0.1mol/L sodium acetate methanol (32∶68). The UV detector was set at 320nm. RESULTS:UV method: The assay linearity was determined in the range of 4～20μg/ml. The average recovery was 99.8%, RSD=0.3%(n=5). HPLC method: The assay linearity was determined in the range of 100～300μg/ml. The average recovery was 100.8%, RSD=0.4%(n=5). The within day and day to day of variations (RSD) were 0.5%(n=5) and 0.9%(n=4) respectively. CONCLUSIONS:There was no difference for the determination of ranitidine hydrochloride and sodium chloride injection by the UV and HPLC method.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2001年第6期471-472,共2页
Chinese Journal of Modern Applied Pharmacy
