Development and Validation of RP-HPLC Method for the Estimation of Nintedanib Esylate in Bulk and Its Formulation

Authors

  • Rohan S. Patil Smt.kashibai Navale college of pharmacy, kondhwa bk. Pune , Maharashtra-48. (Savitribai phule Pune University)
  • Moreshwar P. Mahajan

DOI:

https://doi.org/10.37591/(rrjops).v9i3.140

Abstract

A simple, precise, reliable, rapid and reproducible reversed-phase high performance liquid
chromatographic method (RP-HPLC) method has was developed and validated for the
estimation of Nintedanib Esylate. Chromatography was carried out with analytical
technology. HPLC system consisted of UV-3000-M detector on C18 (4.6×250 mm, 5 μ)
column with a mobile phase composed of methanol:water (80:20 v/v) at a flow rate of
1 ml/min. The pH of the mobile phase was adjusted by 0.05% ortho phosphoric acid (pH-3).
Detection was carried out using a UV detector at 287 nm. Parameters such as linearity,
precision, accuracy, ruggedness, robustness, LOD and LOQ were studied as per the ICH Q2
(R1) guidelines. The retention time was found to be 4.67 min. The linearity range for
Nintedanib esylate was 10–60 μg/ml. The correlation coefficient was found to be 0.999.
Developed method was found to be accurate, precise, selective and rapid for estimation of
Nintedanib esylate in pharmaceutical dosage form. The proposed method can be useful in
quality control of bulk manufacturing and pharmaceutical dosage form.
Keywords: ICH guidelines, method validation, Nintedanib esylate, RP-HPLC

Author Biography

  • Rohan S. Patil, Smt.kashibai Navale college of pharmacy, kondhwa bk. Pune , Maharashtra-48. (Savitribai phule Pune University)
    Quality Assurance department

References

Compound summery of Nintedanib Esylate, Pubchem,

https://pubchem.ncbi.nlm.nih.gov/compound/Nintedanib_esylate#

section=Top

Francesco Varone, Nintedanib for the treatment of idiopathic pulmonary

fibrosis, Expert opinion on pharmacotherapy, 2018, 1465-6566.

Sanjay Popat, Nintedanib plus docetaxcel as second-line therapy in

patients with non-small-cell lung cancer: a network meta-analysis, Future

Oncology, 2014, 10.2217/FON.14.290.

ICH Q2 R1 Text on Validation of Analytical Procedures International

Conference on Harmonized Tripartite Guideline November 2005.1-17.

Broacher for Ofev capsule, Copyright © 2016, Boehringer Ingelheim

Pharmaceuticals, Inc. All rights reserved. (3*16) PC-OF-0325-CONS.

Chemistry review on Ofev Capsule, Center for drug evaluation and

research, Application no. 205832orig1s000.

Downloads

Published

2018-10-16

Issue

Vol. 9 No. 3 (2018)

Section

Research Article

License

Declaration and Copyright Transfer Form

(to be completed by authors)

I/ We, the undersigned author(s) of the submitted manuscript, hereby declare, that the above manuscript which is submitted for publication in the STM Journals(s), is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere.

  • I/We will not withdraw the manuscript after 1 week of submission as I have read the Author Guidelines and will adhere to the guidelines.
  • I/We Author(s ) have niether given nor will give this manuscript elsewhere for publishing after submitting in STM Journal(s).
  • I/ We have read the original version of the manuscript and am/ are responsible for the thought contents embodied in it. The work dealt in the manuscript is my/ our own, and my/ our individual contribution to this work is significant enough to qualify for authorship.
  •  I/We also agree to the authorship of the article in the following order:

Author’s name                                    

 

1. ________________

2. ________________

3. ________________

4. ________________

 

We  Author(s) tick this box and would request you to consider it as our signature as we agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal.