Simultaneous Analysis Of Aliskiren And Hydrochlorothiazide In Pharmaceutical Preparations And Spiked Human Plasma By HPTLC
Authors: Jui J. Pandya, Nejal M. Bhatt, Vijay D. Chavada, Primal Sharma, Mallika Sanyal, Pranav S. Shrivastav
Abstract:
We have developed a precise, selective, and straightforward method utilizing HPTLC for the simultaneous determination of aliskiren and hydrochlorothiazide in fixed-dose tablet formulations and human plasma. Chromatography was conducted on silica gel 60 GF254 plates, using a mobile phase of methanol-chloroform (6:4, v/v). Densitometric analysis was performed at 225 nm. Optimized conditions yielded Rf values of 0.26 ± 0.02 and 0.71 ± 0.02 for aliskiren and hydrochlorothiazide, respectively, with linear regression plots (r2 ≥ 0.9997) within concentration ranges of 1.00–10.0 and 0.10–1.00 μg band−1. The validated method exhibited low limits of detection and quantitation: 0.206/0.624 μg band−1 for aliskiren and 0.015/0.046 μg band−1 for hydrochlorothiazide. Analysis of commercial tablet formulations revealed % expected content of 99.2% for aliskiren and 101.3% for hydrochlorothiazide. For spiked plasma sample preparation, solid-phase extraction using LiChrosep® DVB-HL cartridges was employed to extract the analytes and the nebivolol internal standard from 500 μL of plasma sample. The mean extraction recoveries from human plasma were 87.2% for aliskiren and 76.5% for hydrochlorothiazide. Additionally, the stability of the analytes in plasma was assessed under various storage conditions.
Keywords
High-performance thin-layer chromatography; Aliskiren; Hydrochlorothiazide; Method development; Pharmaceutical formulation; Human plasma
Citation: Jui J. Pandya, Nejal M. Bhatt, Vijay D. Chavada, Primal Sharma, Mallika Sanyal, Pranav S. Shrivastav Simultaneous Analysis Of Aliskiren And Hydrochlorothiazide In Pharmaceutical Preparations And Spiked Human Plasma By HPTLC http://dx.doi.org/10.1016/j.jtusci.2016.05.001
Received: 4 December 2015, Revised: 4 April 2016, Accepted: 3 May 2016, Available online: 13 May 2016
Copyright: © 2016 TheAuthors. Production and hosting by Elsevier B.V.on behalf of Taibah University.This is an open access article under the CCBY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).
Conclusion
A selective and robust HPTLC method has been developed for the determination of ALS and HCTZ in tablet formulation and spiked human plasma following ICH guidelines. This is possibly the first method for the simultaneous estimation of this drug combination in human plasma by any technique. Further, the statistical analysis proves that the method is suitable for analysing ALS and HCTZ in their pure form and in pharmaceutical preparations without any interference from the excipients. The validation data suggest that the proposed densitometric method is reproducible, accurate and precise, and it can be readily applied for pharmacokinetic/bioequivalence studies.
Conflict of interest
None declared.
Acknowledgements
The authors are thankful to the Department of Zoology, Gujarat University and Veeda Clinical Research Pvt. Ltd for providing infrastructure facility to carry out some experiments.
