1* Research Scholar, Sunrise University, Alwar, Rajasthan, India.
2 Dattakala College of Pharmacy, Swami- Chincholi (Bhigwan), Maharashtra, India.
3 Research Scholar, Sunrise University, Alwar, Rajasthan, India.
A reverse phase high performance liquid chromatographic simultaneous estimation (HPLC) was developed and validated as per ICH 2019, US FDA 2018 guidelines for quantification of Ramipril (RAM) and Olmesartan Medoxomil. In present study, Estimatimation of Olmesartan Medoxomil (OLM) and Ramipril (RAM) in tablet formulation, accurate, and affordable approach has been established. Both OLM and RAM are angiotensin-converting enzyme inhibitors, which are antihypertensive drugs. The combination of Ramipril (RAM) and Olmesartan Medoxomil (ATV) in Telmy-R is a particularly effective pharmacological formulation since it increases the efficacy of the separate medications. The current study uses shimadzhu700 and Elico UV spectrophotometers for simultaneous estimation utilising the first derivative approach and RP-HPLC. OLM has zero crossing point at 240nm in methanol and RAM has zero crossing point at 246 nm in methanol. Both these drugs obey Beer’s law in the concentration range employed for the present method. The result of analysis has been validated statistically by recovery studies. The slope and intercept for OLM were 0.0364x and 0.0078 and for RAM were 0.001 and -0.0001 respectively as determined by the method of least squares. Estimation of individual drug in the tablet formulation by Amplitude measurement method (peak to peak) was carried out at first derivative mode. The work is done within the UV range of 230nm to 280nm, where OLM has ?max at 256nm. showing the linearity range between 5-30 µg/ml. The slope and intercept for OLM were 0.4594x and 2.1693 respectively. The result of analysis has been validated statistically by recovery studies. A simple, rapid, and precise reversed-phase high-performance liquid chromatographic method has been developed for simultaneous determination of OLM & RAM. The two drugs are separated on Capcell pack col no. AKAD (05395(4.6 mml D X 250 mm i.d.) C18 column. The mobile phase was 0.005 M Phosphate Buffer–Acetonitrile–Methanol, 60:20:20 (v/v), pH adjusted to 4 with glacial acid, at a flow rate of 1.0 mL min?1. UV detection was performed at 210 nm. The method was validated for linearity, accuracy & precision as per ICH guidelines. The results were found satisfactory and reproducible. The method was applied successfully for the estimation of OLM and RAM simultaneously in tablet dosage form without the interference of common excipients.
Priti R. Kale, Vishal B. Babar, Ashish B. Jadhav, Analytical Method Validated Techniques For The Simultaneous Estimation Of Olmesartan Medoxomil And Ramipril By RP-HPLC Method, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 1, 13-22. https://doi.org/10.5281/zenodo.10450799
10.5281/zenodo.10450799
