摘要
目的以HPLC外标法同时测定复方依那普利片中依那普利(用E代)、氢氯噻嗪(用H代)的含量。方法:采用LUNAC_(18)柱,甲醇——乙醚——0.03mol·L^(-1)磷酸二氢钾(用10％磷酸调pH至3.0)300:7:700为流动相,检测波长为215nm。结果:含量测定方法能较好地分离被测组分和有关杂质,被测组分的线性关系良好,回收率满意,溶出度限度为标示量的75％,均匀度限度为±20％。结论此质量标准能很好地控制成品质量。
OBJIECTIVE quantitative HPLC determination method for hydro chlorothizide and Enalapril Maleate in Compornd Enalapric Tablets. METHODS The LUNA C_(18) column was used. The mobile phase consisted of 0.003mol·L^(-1) phasphate Buffer(pH3.0)-methanol-ether(700: 300: 7), Flow rate 0.8ml· min^(-1) and detection wavelength 215nm. RESULT impurity had no influnce on the assay of the components. The linera been used to determine compound Maleate Enalapric Tablets was high reproducibility. The recovery was satisfactory. The dissolution limit was 75% of content, The uniformity limit was ±20%. Conlusion This quanlity standard was capable to effectively control real quanlity of compound Enalapril Tablets.
出处
《黑龙江医药》
CAS
2001年第4期256-258,272,共4页
Heilongjiang Medicine journal
