alexa Abstract | Analytical Method Development and Validation for Simultaneous Estimation of Telmisartan and Ramipril in Pharmaceutical Dosage Forms by Rp-Hplc


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Research Article Open Access

Abstract

A better and rapid reverse phase HPLC method for the estimation of Telmisartan and Ramipril using UV detection was developed and validated using kromofil-C18 ODS column and the mobile phase composition was phosphate buffer and acetonitrile (50:50) at a flow rate of 0.7 ml/min. The monitoring wavelength used was 215 nm with UV detection the run time was selected to be 8min because the peaks for telmisartan and ramipril were observed around 4.8 min and 3.7min. The method was validated as per ICH guidelines for various parameters like Accuracy, Linearity, Precision, Robustness, Ruggedness, LOD and LOQ studies. The Precision of the System and Method were checked and was found to be within the limits. This indicates that the method is precise. Correlation coefficient was found to be 0.999. The recovery value of pure drugs were found to be between 98.0 % to 102.0 % which indicates that the method is accurate and also reveals that commonly used excipients and additives present in the pharmaceutical formulations were not interfering in the proposed methods. The proposed analytical method passed both Robustness and Ruggedness tests. On both cases, relative standard deviation was well satisfactory. The proposed method can be used for routine analysis of Telmisartan and Ramipril combined commercial tablet dosage form in less time.

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Author(s): Sankar A. S. K., Sunaina Shanmugasundaram P., Viswanath V., Ravichandiran V.

Keywords

ICH guidelines, reverse phase HPLC, ramipril, telmisartan., Pharmaceutical Sciences

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