Method Development and Method Validation for Ramipril and Telmisartan by RP-HPLC in Pharmacentical Dosage form.

The present study from the literature survey conducted, it was found that there are few analytical methods reported for Ramipril and Telmisartan by reverse phase HPLC method alone or in combination with other drugs. Presently the new formulation of Ramipril and Telmisartan is available in market. There are only few methods reported for the determination of Ramipril and Telmisartan in combined pharmaceutical dosage form. So it was felt that there is a need to develop a sensitive analytical method for the simultaneous estimation of Ramipril and Telmisartan in Tablet dosage form available in market. AIM: To develop a sensitive, simple, rapid and accurate analytical method for the simultaneous estimation of Ramipril and Telmisartan in formulations and validation of developed method by using RP-HPLC technique. OBJECTIVE: The scope of developing and validating method is to ensure a suitable strategy for a particular analyte which is more specific, accurate and precise. Here the main focus is drawn to achieve improvement in conditions and standard operating procedures to be followed. To develop a method that is rapid, sensitive and at the same time cost effective. CONCLUSION: From the reported literature, there were few methods established for the determination of Ramipril and Telmisartan in individual and in combination with other drug. It was concluded that there were only few methods reported for the simultaneous estimation of the above selected multi component dosage form, which promote to pursue the present work. The scope and objective of the present work is to develop and validate a new simple RP-HPLC method for simultaneous estimation of Ramipril and Telmisartan in combined dosage form. In simultaneous RP-HPLC method development, Waters 2695 Separations Module with PDA Detector and column used is C8 SB ZORBAX (150 X 4.6mm) column with3.5-micron particle size. Injection volume of 10 μL is injected and eluted with the mobile phase selected after optimization was Phosphate buffer and Acetonitrile in the ratio of 70:30 was found to be ideal. The flow rate was found to be optimized at 1.0 mL/min. Detection was carried out at 230 nm. This system produced symmetric peak shape, good resolution and reasonable retention times of Ramipril and Telmisartan were found to be 2.275 and 4.261 minutes respectively. The Ramipril and Telmisartan showed linearity in the range of 20-60 μg/mL and 160-480 μg/mL respectively. Precision of the developed method was studied under system precision and method precision. The %RSD values for precision was found to be within the acceptable limit, which revealed that the developed method was precise. The developed method was found to be robust. The %RSD value for percentage recovery of Ramipril and Telmisartan was found to be within the acceptance criteria. The results indicate satisfactory accuracy of method for simultaneous estimation of the Ramipril and Telmisartan