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

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...

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Veröffentlicht in:Journal of pharmaceutical analysis 2013-12, Vol.3 (6), p.440-446
Hauptverfasser: Dai, Shi-Ying, Qiu, Shi-Ting, Wu, Wei, Fu, Chun-Mei
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Sprache:eng
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Zusammenfassung: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.
ISSN:2095-1779
2214-0883
DOI:10.1016/j.jpha.2013.09.002