METHOD DEVELOPMENT AND VALIDATION OF FAST DISSOLVING TABLET OF RAMIPRIL BY HPLC METHOD
Abstract
Objective: The Objective of present work is method development and validation of HPLC method for the quantitation of Ramipril in Fast dissolving tablet (FDT).
Methods: A stable, linear, rapid, accurate and selective HPLC method has been developed for the quantification of Ramipril in FDT using buffer and acetonitrile: methanol (60:40 v/v) ratio in combination as mobile phase and at the flow rate of 1 ml/minute at λmax 210 nm. Chromatographic separation was performed on Shimadzu SPD-20A, SD-M10 AVP-Shimadzu, an ODS C-18 Kromacil (250 mm × 4.60 mm) column used as stationary phase. The quantitation of Ramipril done by HPLC, parameters studied were retention time, linearity, accuracy, precision, detection limit, quantitation limit and stability.
Results: Linear regression analysis data show a good linear relationship between response and concentration in the range of 5-30 µg/ml; detection carried out at λmax210 nm; the linear regression equation for Ramipril was Y=10327x+72877; R²=0.998. The retention time of the Ramipril was 2.910 min. Percent recoveries obtained for Ramipril was 99.58-100.15%. LOD and LOQ value was 0.802µg/ml and 1.4µg/ml for Ramipril respectively.
Conclusion: The result suggested that proposed method gives good peak resolution of Ramipril within short analysis time (<10 min) and high percentages of the recovery shown that method is free from interference of excipient present in the formulation. The % RSD of each parameter lies below the limit of 2%, proven the suitability. The statistical analysis proved that the proposed method is precise, accurate, selective and rapid for the HPLC estimation of Ramipril.
Keywords: Fast dissolving tablet, Ramipril, Accuracy, HPLC, Linearity
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References
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