Development and validation of an RP-HPLC method for simultaneous determination of Ramipril and Amlodipine in tablets  

作　　者：Shi-Ying Dai Shi-Ting Qiu Wei Wu Chun-Mei Fu 

机构地区：[1]Key Laboratory of Drug Targeting and Drug Delivery System,Ministry of Education,West China School of Pharmacy, Sichuan University

出　　处：《Journal of Pharmaceutical Analysis》2013年第6期440-446,共7页药物分析学报（英文版）

摘　　要：AnRP-HPLC method for the simultaneous determination ofRamipril （RP） andAmlodipine （AL） in tablets was developed and validated by Chinese Pharmacopoeia 2010. The linearity of the proposed method was investigated in the range of 0.01-0.25 mg/mL （r^2=0.9998） for RP and 0.014-0.36 mg/mL （r^2=0.9997） for AL. The limits of detection （LOD） were 0.06 lag/mL and 0.02 μg/mL for RP and AL, and the limits of quantitation （LOQ） were 0.2 Dg/mL and 0.07 μg/mL, respectively. Some major impurities and degradation products did not disturb the detection of RP and AL and the assay can thus be considered stability-indicating.AnRP-HPLC method for the simultaneous determination ofRamipril （RP） andAmlodipine （AL） in tablets was developed and validated by Chinese Pharmacopoeia 2010. The linearity of the proposed method was investigated in the range of 0.01-0.25 mg/mL （r^2=0.9998） for RP and 0.014-0.36 mg/mL （r^2=0.9997） for AL. The limits of detection （LOD） were 0.06 lag/mL and 0.02 μg/mL for RP and AL, and the limits of quantitation （LOQ） were 0.2 Dg/mL and 0.07 μg/mL, respectively. Some major impurities and degradation products did not disturb the detection of RP and AL and the assay can thus be considered stability-indicating.

关 键 词：RAMIPRIL AMLODIPINE RP-HPLC STABILITY-INDICATING 

分 类 号：R927[医药卫生—药学]