• Pragati Ranjan Satpathy
• Madhuchhanda Mishra
• Dr. Nilima Shukla
• Chinmay Kumar Kar
• Dr. Mihir Kumar Kar

ABSTRACT A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Fimasartan in bulk form and marketed formulation. Separation of Fimasartan was successfully achieved on a Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm i.d.column in an isocratic mode of separation utilizing Methanol : Phosphate buffer (0.02M, pH-3.6) in the ratio of 45:55% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 12-28mcg/mL for Fimasartan.The correlation coefficient was found to be 0.9995 for Fimasartan. The LOD and LOQ for Fimasartan were found to be 5.004µg/mL and 15.164µg/mL respectively. The proposed method was found to be good percentage recovery for Fimasartan, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

Keywords:Fimasartan, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.

"DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF FIMASARTAN IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.13, Issue 10, page no.b118-b129, October-2026, Available :http://www.jetir.org/papers/JETIR2610115.pdf

"DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF FIMASARTAN IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.13, Issue 10, page no. ppb118-b129, October-2026, Available at : http://www.jetir.org/papers/JETIR2610115.pdf