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Development and validation of an RP-HPLC method for simultaneous determination of Ramipril and Amlodipine in tablets 被引量:1

Development and validation of an RP-HPLC method for simultaneous determination of Ramipril and Amlodipine in tablets
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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.
出处 《Journal of Pharmaceutical Analysis》 SCIE CAS 2013年第6期440-446,共7页 药物分析学报(英文版)
关键词 RAMIPRIL AMLODIPINE RP-HPLC STABILITY-INDICATING Ramipril Amlodipine RP-HPLC Stability-indicating
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