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Development and Validation of Assay Method of Amlodipine Tablet by HPLC

Keywords: Method validation , HPLC , Assay , Stability , Amlodipine.

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A simple, selective and rapid reversed phase high performance liquid chromatographic (RPHPLC) method for the analysis of amlodipine in tablet has been developed and validated. The separation was achieved from octadecylsilyl silica gel, C18 (3.9 mm x 150 mm) column with a mobile phase consisting of HPLC grade acetonitrile, methanol and triethylamine solution (15: 35: 50) ata flow rate of 1ml/min with UV detection at 237nm at 300C column temperature. The method was specific and the assay result of spiked sample (with placebo) was unaffected by the presence of placebo (by comparison with the assay results obtained on unspiked sample). The proposed method was accurate with 100.29% recovery for amlodipine and precise (% RSD of area of system precision, % RSD of assay of method precision and intermediate precision were found 0.33%, 0.34% and 0.17% respectively). From the linearity study the correlation coefficient was found 0.9999, which indicated that the method was linear over 50% to 150% range. The method was found robust for possible changes. Therefore, this method can be used as a more convenient and efficient option for the analysis of amlodipine in tablet dosage form to establish the quality of the drug product during routine analysis with consistent and reproducible results.


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