Issue

Vol. 32 No. 6 (2020): Vol 32 Issue 6

Copyright (c) 2020 AJC

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Validated HPLC Method for Assay and Content Uniformity Testing of Roflumilast in Blend and Tablets

https://doi.org/10.14233/ajchem.2020.22373
N. Nukendra Prasad
Division of Chemistry, Department of Sciences and Humanities, Vignan′s Foundation for Science, Technology and Research-VFSTR (Deemed to be University), Vadlamudi, Guntur-522213, India; AET Laboratories, Research and Development, Hyderabad-502319, India
https://orcid.org/0000-0001-5524-5089
R. Venkata Nadh
Department of Chemistry, GITAM University, Bengaluru-561203, India
https://orcid.org/0000-0003-0925-1132
N. Srinivasu
Division of Chemistry, Department of Sciences and Humanities, Vignan′s Foundation for Science, Technology and Research-VFSTR (Deemed to be University), Vadlamudi, Guntur-522213, India
https://orcid.org/0000-0002-4900-1907

Corresponding Author(s) : N. Nukendra Prasad

prasadnn14@gmail.com

Asian Journal of Chemistry, Vol. 32 No. 6 (2020): Vol 32 Issue 6

Abstract

Roflumilast is a selective enzyme inhibitor of phosphodiesterase-4. This drug is recommended for treatment of patients suffering from chronic-obstructive-pulmonary-disease with chronic-bronchitis. Roflumilast is not official in pharmacopoeia and the reported methods are having high chromatographic run times. A short run time HPLC method was developed for assay and content uniformity testing to determine the roflumilast in blend and tablets. The mobile phase consists of 10 mM sodium dihydrogen phosphate monohydrate buffer and acetonitrile in the ratio of 45:55 v/v. The HPLC method was developed using accucore-C18 150 × 4.6 mm, 4 μm column with a flow rate of 1.0 mL min-1, 215 nm wavelength and 10 μL injection volume with run time of 5 min. The method linearity was proved between 5.02-40.17 μg mL-1 and obtained correlation-coefficient value is 1.0000. The mean recovery of roflumilast was 100.6%. The stability indicating nature was established and performed the validation by considering ICH Q2 (R1) recommendations.

Keywords

Roflumilast Content uniformity HPLC method
Prasad, N. N., Nadh, R. V., & Srinivasu, N. (2020). Validated HPLC Method for Assay and Content Uniformity Testing of Roflumilast in Blend and Tablets. Asian Journal of Chemistry, 32(6), 1279–1285. https://doi.org/10.14233/ajchem.2020.22373
Download Citation
Endnote/Zotero/Mendeley (RIS)
BibTeX
References
  1. N.A. Pinner, L.A. Hamilton and A. Hughes, Clin. Therap., 34, 56 (2012); https://doi.org/10.1016/j.clinthera.2011.12.008
  2. V.D. Barhate and P.C. Deosthalee, J. Chem. Pharm. Res., 3, 720 (2011).
  3. A. Suganthi, K. Arthi and T.K. Ravi, Indian J. Pharm. Sci., 79, 287 (2017); https://doi.org/10.4172/pharmaceutical-sciences.1000227
  4. J. Varaprasad, P.V.N. Kumar, P. Srinivasu, L.A. Ramaprasad and R. Ramakrishna, Indian J. Adv. Chem. Sci., 6, 142 (2018).
  5. T. Guray, Quim. Nova, 42, 522 (2019); https://doi.org/10.21577/0100-4042.20170371
  6. N.G. Knebel, R. Herzog, F. Reutter and K. Zech, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 893-894, 82 (2012); https://doi.org/10.1016/j.jchromb.2012.02.038
  7. B.G. Raveendra, S.S.B. Kiran, V.M. Kumari, R.K. Jyothi and D.M. Bhavani, Pharm. Anal. Acta, 7, 487 (2016); https://doi.org/10.4172/2153-2435.1000487
  8. ICH Guideline Q2 (R1), Validation of Analytical Procedures: Text and Methodology (1996).
  9. J. Ermer and J.H.McB. Miller, Textbook of Method Validation in Pharmaceutical Analysis, WILEY-VCH Verlag, GmbH & Co (2006).
  10. N.P. Nadella, V.N. Ratnakaram and N. Srinivasu, J. Liq. Chromatogr. Rel. Technol., 40, 517 (2017); https://doi.org/10.1080/10826076.2017.1330211
  11. N.P. Nadella, V.N. Ratnakaram and N. Srinivasu, J. Liq. Chromatogr. Rel. Technol., 41, 143 (2018); https://doi.org/10.1080/10826076.2018.1427595
Read More
Author biographies is not available.
Download
PDF
Statistic
Read Counter : 6 Download : 1