摘要
目的 :建立一种用高效液相色谱法测定盐酸维拉帕米及其片剂和注射剂的含量及有关物质的方法。方法 :以ODS为固定相。醋酸盐缓冲溶液 -甲醇 -三乙胺 ( 5 5∶4 5∶1)为流动相 ,检测波长为 2 78nm。结果 :盐酸维拉帕米的浓度在 0 0 5～ 1 0mg·mL-1范围内线性关系良好 ,回归方程 :Y =1 0 8× 10 3+3 0 13× 10 5X ,r =0 9999。精密度试验RSD =0 2 % (n =10 ) ,最低检出限为 0 1μg·mL-1(S/N =3 )。片剂、注射剂回收率(n =6)分别为 99 5 % (RSD =0 4 % ) ;10 1 1% (RSD =0 2 % )。有关物质可检出 4个杂质。结论 :本方法简单、快速、结果准确。
Objective:A HPLC method was established for the determination of verapamil hydrochloride,its tablet,injection and related compounds.Method:Verapamil hydrochloride was separated on an ODS column with the mobile phase of acetate buffer-methanol-triethylamine(55∶45∶1) and detected at 278 nm.Results:The standard curve was linear in the range of 0 05～1 0 mg·mL -1 and the correlation coefficient was 0 999 9.The precision of verapamil hydrochloride was good( RSD =0 2%, n =10)and the average recovery of the tablet was 99 5%( RSD =0 4%, n =6)and that of the injection was 101 1%( RSD =0 2%, n =6).Conclusion:The proposed method is simple,rapid,accurate and reliable.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2000年第2期113-115,共3页
Chinese Journal of Pharmaceutical Analysis
