Development and Validation of a New Stability-Indicating HPLC Method for the Determination of Rosiglitazone in Tablets

Authors

  • K. Basavaiah Department of Chemistry, University of Mysore, Manasagangothri, Mysuru, Karnataka, India
  • N. Rajendraprasad PG Department of Chemistry, JSS College of Arts, Commerce and Science, BN Road, Mysuru, Karnataka, India

DOI:

https://doi.org/10.37591/(rrjops).v8i1.479

Abstract

 

Rosiglitazone (ROS) is an antidiabetic drug belonging to the thiazolidine class. A new stability-indicating high-performance chromatographic (HPLC) method was developed for the determination of ROS in pharmaceuticals, and validated for its suitability following the ICH guidelines. Chromatography was performed on a Chromatopack (250×4.6 mm; 5 µm particle size) column using phosphate buffer of pH 3.2 and methanol (70:30 v/v) as mobile phase pumped at a flow rate of 1 ml min-1 with UV-detection at 220 nm. The influences of mobile phase composition, buffer pH, flow rate and column temperature on the retention behaviour of the analyte were carefully studied and optimized. Quantification was based on peak area measurement and mean peak area-concentration plot was linear (r = 0.9999) over 7–525 µg mL-1 concentration range. Robustness of the method was assessed by performing the analysis under slightly altered chromatographic conditions; whereas ruggedness was determined with analysis being done by different analysts using different columns. The method was found to be selective as shown by results of placebo and synthetic mixture analyses. The method was applied to the determination of ROS in tablets and the results agreed well with the label claim and those obtained by a reference method. As part of degradation study, ROS was subjected to forced degradation under acid, base, oxidant, heat and light-induced stress conditions, and the results indicated that the drug was susceptible to base and oxidant-induced stress conditions and inert to other stress conditions.

 

Keywords: Rosiglitazone, determination, HPLC, pharmaceuticals, stability-indicating

Cite this Article

Basavaiah K, Rajendraprasad N. Development and Validation of a New Stability-Indicating HPLC Method for the Determination of Rosiglitazone in Tablets. Research and Reviews: A Journal of Pharmaceutical Science. 2017; 8(1): 1–9p.

Downloads

Published

2019-06-19

Issue

Vol. 8 No. 1 (2017)

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.