Vol 14, Issue 2, 2021 Online - 2455-3891 Print - 0974-2441 STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FIMASARTAN BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND PHARMACEUTICAL DOSAGE FORM SRUTHI A*, UTTAM PRASAD PANIGRAHY Department of Pharmaceutical Analysis, CMR College of Pharmacy, Hyderabad, Telangana, India. Email: uttampanigrahy@gmail.com Received: 23 October 2020, Revised and Accepted: 2 December 2020 ABSTRACT Objective: A rapid, sensitive and specific reverse phase High performance liquid Chromatography (RP-HPLC) method was developed for the estimation of Fimasartan in bulk and pharmaceutical dosage form. Method: The RP-HPLC analysis was performed isocratically on a Primacel C 18 column (150 mm × 4.6 mm internal diameter, 5 μm particle size) using mobile phase of composition Acetonitrile and 0.1% orthophosphoric Acid in 80:20, v/v proportions with a flow rate of 0.8 ml/min. Results: The analyte was monitered with UV-detector at 265 nm. In the developed method Fimasartan elutes at a typical retention time of 2.4 min. The proposed method is having linearity in the concentration ranging from 5-30 μg/ml of Fimasartan. Conclusion: : The method was statistically validated and had been applied to analysis of the drug in bulk and pharmaceutical dosage form. Keywords: Fimasartan, Reverse-phase high-performance liquid chromatography, C 18 column. INTRODUCTION Fimasartan is a typical anti-hypertensive agent. Fimasartan acts on the kidney’s rennin-angiotensin cascade, which begins when renin release from the kidney causes the breakdown of angiotensinogen into angiotensin I. In blocking the AT 1 receptor, Fimasartan inhibits vasoconstriction favoring vasodilation. Fimasartan is chemically known as 2-[2-butyl-4-methyl-6- oxo-1-[[4-[2-(2H-tetrazol-5-yl) phenyl] phenyl] methyl] pyrimidin-5-yl]-N and N-dimethylethanethioamide shown in Fig. 1. Literature survey reveals the availability of few methods such as ultraviolet (UV), high-performance liquid chromatography (HPLC), and LC-MS in biological fluids and pharmaceutical dosage forms [1-16]. The present method gives the accurate information regarding method development and validation of Fimasartan in bulk and pharmaceutical dosage form using UV detector at 265 nm which is simple, accurate, economic, rapid, reproducible, and sensitive according to procedures and acceptance criteria based on FDA guidelines and recommendations of ICH. METHODS Chemical and reagents Fimasartan was procured as gift sample from Metrochem Pvt. Ltd., Hyderabad, India. Fimanta ® 120 mg (formulation) was manufactured by Ajanta Pharma Limited. HPLC grade acetonitrile, HPLC grade water, and orthophosphoric acid were obtained from Merck, Hyderabad, India. All other chemical reagents used were of analytical grade. Selection of wavelength Wavelength was selected by dissolving Fimasartan in suitable solvent (acetonitrile) and the resulting solution was scanned in UV region, that is, 200–400 nm. Fimasartan has showed that maximum absorption at 265 nm was selected shown in Fig. 2. Chromatographic conditions A Shimadzu HPLC was used for the analysis of the entire method. The method was carried out on Primacel C 18 (150 mm × 4.6 mm i.d., 5 μm) column as a stationary phase and Acetonitrile:0.1% OPA (80:20,v/v) as the mobile phase at a flow rate of 0.8 ml/min. Rheodyne injector with 25 μl loop was used for injecting the samples. Finally, the sample was analyzed at 265 nm and the mobile phase was sonicated filtered and degassed. Preparation of mobile phase Acetonitrile and 0.1% OPA in the ratio of 80:20 v/v were used as a mobile phase for present study which is prepared by dissolving 80 ml of acetonitrile and 20 ml of 0.1% OPA in a reservoir. 0.1% orthophosphoric acid was prepared by accurately measuring of 0.1 ml of OPA and dissolving in 100 ml of HPLC grade water. The above mobile phase prepared is sonicated and degassed. Preparation of standard solution Standard solution was prepared by accurately weighing 100 mg of Fimasartan and transferring into 100 ml volumetric flask. To this add few ml of acetonitrile and dissolve the drug properly. Finally make up the solution to 100 ml with acetonitrile (1000 μg/ml). Preparation of sample solution Tablet powder equivalent to 100 mg of Fimasartan was accurately weighed and transferred into 100 ml volumetric flask and make up the volume to 100 ml with acetonitrile. Sonicate the solution for about 15 min and filter the solution through Whatman filter paper (No. 1) into another 100 ml volumetric flask (1000 μg/ml). The solution was further diluted with the diluent to the working concentration range of calibration curve. Calibration curve Ten milliliters of standard solution were transferred into 100 ml volumetric flask and the volume was made up to 100 ml using acetonitrile (100 μg/ml). From this solution, further dilutions were made in the concentration range of 5 μg/ml–30 μg/ml. Further these concentrations were injected thrice into the system and the calibration curve was constructed by plotting concentration on X-axis and peak area on Y-axis. © 2021 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/ licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ajpcr.2021v14i2.39919. 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