Stability Indicating Method Development and Validation of Fimasartan by RP-HPLC in Bulk and Pharmaceutical Dosage form.
Method Development and Validation of Fimasartan by RP-HPLC in Bulk and Pharmaceutical Dosage form.
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 C18 column (150 mm×4.6mm internal diameter, 5μm particle size) using mobile phase of composition Acetonitrile and 0.1% orthophosphoric Acid in 80:20, v/v proportions with a flow rate of 0.8ml/min.
Results: The analyte was monitered with UV- detector at 265nm. In the developed method Fimasartan elutes at a typical retention time of 2.4min. The proposed method is having linearity in the concentration ranging from 5-30μg/ml of Fimasartan.
Conclusion: The method was statistically validated and had been applied to analysis of the drug in bulk and pharmaceutical dosage form.
2. Pandya CP, Rajput SJ. Validated stability indicating RP-HPLC method for the determination of Fimasartan in presence of degradation products. Indo American Journal of Pharmaceutical Research 2017; 7: 2231-6876.
3. Moon HW, Yousaf AM, Cho KH, Yong CS. Evaluation of stability and simultaneous determination of fimasartan and amlodipine by a HPLC method in combination tablets. Asian journal of pharmaceutical sciences 2014; 9: 123-128.
4. Mohammed ABWE, Rudwan EH. RP-HPLC method development and validation of stability indicating method a for estimation of losartan potassium under stress condition and tablet dosage form. International journal of pharmaceutical sciences and research 2016; 7: 2343-2351.
5. Sumithra M, Shanmugasundaram P, Sankar ASK, Niharika. Method Development and Validation of Losartan Potassium by RP-HPLC. Research Journal of Pharmaceutical Biological and Chemical Sciences 2012; 3: 463-478.
6. Paladugu ND, Rao GD, Satyanarayana B, Poloju D. Development and Validation of RP-HPLC method for quantification of Valsartan and its Pharmaceutical Formulations. International journal of Drug Development and Research 2013; 5: 199-205.
7. Pal R, Padma S, Bhargav Y, Reddy GR. RP-HPLC Method Development and Validation of Valsartan in Bulk and its Tablet Dosage Form. Journal of Biomedical and Pharmaceutical Sciences 2019; 2: 122.
8. Vinzuda DU, Sailor GU, Sheth NR. RP-HPLC Method for Determination of Valsartan in Tablet Dosage Form. International Journal of ChemTech Research 2010; 2: 1461-1467.
9. Haque MA, Amrohi SH, Kumar KP, Nivedita G, Kumar TP, Mohanty D, Diwan VP. Stability indicating RP-HPLC method for the estimation of Valsartan in pharmaceutical dosage form. IOSR Journal of Pharmacy 2012; 2: 12-18.
10. Siddiqui MMA, Qasim SS, Abueida EY. Isocratic RP-HPLC method validation and verification of losartan potassium in pharmaceutical formulations with stress test stability for drug substance. Der Pharmacia Lettre 2011; 3: 160-167.
11. Panigrahy UP, Kumari K, Reddy T, Abbulu K. RP-HPLC Method Development and Validation for Simultaneous Estimation of Prazosin and Polythiazide in Bulk and Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology 2020; 13: 1779-1789.
12. Masthanamma SK, Pradeepthi, Jahnavi. RP-HPLC method for determination of Azilsartan medoxomil in pharmaceutical dosage form. Research Journal of Pharmacy and Technology 2014; 7: 168-172.
13. Bhadoriya U, Dhaked H, Danodia AK. RP-HPLC method development and validation for estimation of telmisartan in bulk and tablet dosage form. International Journal of Drug Regulatory affairs 2013; 1: 61-64.
14. Raghu Babu K, Sarma ESRS, Kumari NA, Raju GMJ, Sarma GVS. Simple and stability indicating RP-HPLC assay method development and validation of telmisartan in bulk and dosage form. Der Pharmacia Lettre 2015; 7: 274-280.
15. Patro SK, Kanungo SK, Patro VJ, Choudhury NSK. Stability Indicating RP-HPLC Method for Determination of Valsartan in Pure and Pharmaceutical Formulation. Journal of Chemistry 2009; 7: 1-7.
16. Kore RS, Mahaparale SP, Bhagat AP. Stability Indicating RP-HPLC Method Development And Validation For Estimation Of Azilsartan Medoxomil In Tablet Dosage Form World Journal of Pharmaceutical Research 2019; 8: 1023-1035.
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.