METHOD DEVELOPMENT AND VALIDATION OF FAST DISSOLVING TABLET OF RAMIPRIL BY HPLC METHOD
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 Î»max 210 nm. Chromatographic separation was performed on Shimadzu SPD-20A, SD-M10 AVP-Shimadzu, an ODS C-18 Kromacil (250 mm Ã— 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 Âµg/ml; detection carried out at Î»max210 nm; the linear regression equation for Ramipril was Y=10327x+72877; RÂ²=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 0.802Âµg/ml and 1.4Âµg/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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