RP-HPLC Method Development and Validation for the Estimation of Mirabegron in Bulk and Dosage Form

  • Rahul Suryawanshi Department of Quality Assurance, S.N.D College of Pharmacy Babhulgaon, India
  • Siddiqua Shaikh Department of Quality Assurance, S.N.D College of Pharmacy Babhulgaon, India
  • Snehal Patil Department of Quality Assurance, S.N.D College of Pharmacy Babhulgaon, India


A new, simple, precise, accurate and reproducible Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Mirabegron was successfully achieve , C18, 250X4.6mm, 5µm or equivalent in an isocratic mode utilizing methanol water (70:30) at pH 5.0 Adjusted to OPA at a flow rate of 1.0ml/min and eluate was monitored at 243nm, with a retention time of 2.584 minutes for Mirabegron. The method was validated and the response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Mirabegron. The values of the correlation coefficient were found to 0.999for Mirabegron. The Limit of Detection(LOD) and Limit of Quantification (LOQ) for Mirabegron were found to be 0.149 and 0.498 respectively. This method was found to be good percentage recovery were found to be 99 indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to International Council for Harmonisation(ICH) guidelines for Linearity, Accuracy, Precision, Specificity and

Keywords: RP-HPLC, ICH, Mirabegron


Download data is not yet available.


] Harris, Daniel C. (2006), Quantitative Chemical Analysis, 7th Edition, W. H. Freeman
2] Mermet, Jean-Michel, Otto, Matthias and Valcarcel Cases, Miguel (2005), Analytical
chemistry : a modern approach to analytical science, 2nd Edition, Wiley-VCH
3) Townshend A. (1995) Encyclopaedia of Analytical Science, Volumes 1-10, Academic Press, London.
4] Jaarinen and Niiranen 2005, Molnár and Horváth 1976, Wohlgemuth 2011, pp. 116-159.
5] Ettre, Leslie S. (2001). "The Birth of Partition Chromatography. LCGC. 19 (5), pp. 506–512.
6] Ion Exchange Chromatography Principles and Methods. General Electric Company. 2004. pp. 11–20.
7] ungbauer, Alois; Hahn, Rainer (2009)."Chapter 22 Ion-Exchange Chromatography". Guide to Protein Purification, 2nd Edition. Methods in Enzymology. 463. pp. 349–371.
8] Skoog, D. A.; Principles of Instrumental Analysis, 6th ed.; Thompson Brooks/Cole: Belmont, CA, 2006, Chapter 28.
9] Allocati N, Federici L, Masulli M, Di Ilio C (2009) Glutathione transferases in bacteria. FEBS J 276: 58-75.
0] Skoog D A, Holler F J, Crouch S. R. Instrumental Analysis, 6thed, Thomson Brook/cole, 2007, pp. 13-16, 378-385, 901-905, 893-900.
1] Molnár and C Horváth (September 1976). "Reverse-phase chromatography of polar biological substances: separation of catechol compounds by high-performance liquid chromatography". Clinical Chemistry. 22 (9): 1497–1502.
2] Scott R P W, Technique and Practice of chromatography, Marcel Dekker, New York, 70, pp. 1-12.
3] ICH, Q2R1, Text on validation of analytical Procedures International Conference on harmonization, Geneva, 1994, October, pp. 1-13.
4] Jyothsna M et al., IOSR-JPBS, Volume 13(1), 2018, pp. 78-83.
5] Paisa G R and Rao R A, / Journal of Pharmacy Research, 2017,11(6), pp. 682-685
6] Rani et al., World Journal of Pharmaceutical Research, Volume 6(14), 2017, pp. 750-767.
7] Raveendra et al., World Journal of Pharmacy and Pharmaceutical Sciences, Volume 6(5), 2017, pp. 912-925.
8] Spandana R et al., Indo American Journal of Pharmaceutical Research, Volume, 6(11), 2016 pp. 6860-6886.
19] Zhou et al., Journal of Chromatographic Science, Volume 53, 2015, pp. 1361–1365.
20] Narasimharajuet. al., Am. J. PharmTech Res. Volume, 2012, 2(6), pp. 564-571.
2 ] Mounika B.et al., Int J Curr Pharm Res, Volume 9(5), pp. 140-151.
22] Rezaei M. et al., J. Med. Chem. Sci., Volume 1, pp. 36-40.
23] Sethi P D, HPLC Quantitative Analysis of Pharmaceutical Formulations. CBS Publishers & Distributors, first edition 2001.
24] Scott PWR, Liquid Chromatography for the Analyst. New York: Marcel Dekker Inc. 1994:1-10.
25] International Conference on Harmonization (ICH), Q2A: Text on Validation of Analytical Procedures, March 1995.
26] International Conference on Harmonization (ICH), Q2B: Validation of Analytical Procedures: Methodology,
656 Views | 404 Downloads
How to Cite
Suryawanshi R, Shaikh S, Patil S. RP-HPLC Method Development and Validation for the Estimation of Mirabegron in Bulk and Dosage Form. JDDT [Internet]. 15Jan.2020 [cited 26Jan.2022];10(1):31-8. Available from: http://jddtonline.info/index.php/jddt/article/view/3829