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Development and validation of an rp-hplc method for simultaneous determination of Ramipril and Amlodipine in tablets
Shi-Ying Dai1, Shi-Ting Qiu1, Wei Wu1
1Key Laboratory of Drug Targeting and Drug Delivery System, Ministry of Education, West China School of Pharmacy, Sichuan University, No. 17, Block 3, Southern Renmin Road, Chengdu 610041, China.
Abstract:
An rp-hplc method for the simultaneous determination of Ramipril (RP) and Amlodipine (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 (r2=0.9998) for RP and 0.014-0.36 mg/mL (r2=0.9997) for AL. The limits of detection (LOD) were 0.06 μg/mL and 0.02 μg/mL for RP and AL, and the limits of quantitation (LOQ) were 0.2 μg/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.
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