摘要
目的 建立离子对 -HPLC法测定舒脉注射液中盐酸培他啶含量的方法。方法 采用HypersilODS2色谱柱 (4 .6×2 5 0mm ,5 μm) ;以甲醇 - 1 0mmol·ml-1 醋酸钠溶液 (含有 5mmol·ml-1 庚烷磺酸钠 ,0 .2 %三乙胺 ,用冰醋酸调pH至 3.0 ) ,(4 0∶6 0 )为流动相 ;流速 1 .0ml/min ;检测波长 :2 6 0nm ;柱温为室温。结果 离子对 -HPLC法测定盐酸培他啶的线性范围为 2 1～ 1 0 5 μg·ml-1 ;相关系数 r=0 .9997;日内精密度 RSD =1 .5 % ,日间精密度 RSD =2 .6 % (n=5 ) ;平均回收率为 98.0 %。结论 本法简便、准确。
Aim A HPLC method was established for the determination of betahistine hydrochloride in Shumai Injection.Methods The separation was performed on a Hypersil ODS2 column (4.6×250mm,5μm).The mobile phase was composed of methyl alcohol-5 mmol·ml -1 sodium heptylsufonate and 0.2% triethylamine in 10mmol·ml -1 sodium acetate trihydrate (pH 3.0) (40∶60).The flow rate was 1.0ml/min.The detection wavelength was 260nm.Column temperature was room temperature.Results The calibration curve of betahistine hydrochloride was linear between 21～105μg·ml -1 (r=0.999 7).Intra-day and inter-day RSD were 1.5% and 2.6%(n=5).The average recovery was 98.0%.Conclusion The method is simple,accurate and suitable for the determination of betahistine hydrochloride.
出处
《解放军药学学报》
CAS
2003年第5期383-385,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
