Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

A reversed phase HPLC method for simultaneous estimation of rosuvastatin calcium and telmisartan in bulk and pharmaceutical formulations has been developed and validated. An isocratic conditioning mixtures of 0.02 M phosphate buffer at pH 4.8, acetonitrile, and methanol in the ratio of 35:35:30 (v/v/v) were used as a mobile phase. Phenomenex Luna C-18 (250 mmx4.6 mmx5 μ) stationary phase were found to be the suitable. A 1 mL/min flow rate, 298 nm detection wave length and ambient temperature were also best suited for analysis. Based on these conditions, the retention times obtained for rosuvastatin and telmisartan are found to be 4.55 and 5.22 min and their corresponding tailing factors are 1.44 and 1.54, respectively. The peaks were also well resolved (Rs=3.645). The method was validated by determining the linearity, precision and accuracy, LOD & LOQ, and solution stability as per ICH guidelines. Linearity plot were constructed between the concentration range of 50-400 μg/mL for rosuvastain and 10-410 μg/mL for telmisartan and it was found to be linear (r 2 =0.999 for each) and the LOD and LOQ (1.132 and 3.43 μg/mL for rosuvastatin and 0.727 and 2.204 μg/mL for telmisartan, respectively). Both precision and accuracy were determined and as the % RSD testifies, the method is accurate and precise. Bench top solution stability was conducted to the working solutions of the drugs and the results suggest that, the solutions are stable up to 24 hrs. Thus, the results obtained in this study proved that the developed method is simple, reliable, precise, and accurate.

Biography

Gebremariam Ketema has completed his M.Sc. degree at the age of 27 from Addis Ababa University, School of Pharmacy and Ph.D. at the age of 32 years from Andhra University. Previously, he was working as a Quality Control chemist in Ethio Leather Industry Pvt. Ltd. Co., now he is an academic staff of Wollo University. Prior to his Ph.D. study, he was working as a lecture, head of department and deans for College of Medicine and Health Sciences. He has been awarded C V Raman International Fellowship for African Researchers. He has published more than 5 papers in reputed journals.