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:

A simple, selective and precise method based on HPTLC has been developed for the simultaneous determination of aliskiren and hydrochlorothiazide in a fixed-dose tablet formulation and human plasma. The chromatography was performed on silica gel 60 GF254 plates, with a mobile phase consisting of methanol–chloroform (6:4, v/v). Densitometric analysis of the analytes was carried out at 225 nm. Under optimized conditions, the Rf values were 0.26 ± 0.02 and 0.71 ± 0.02, and the resulting regression plots were linear (r2 ≥ 0.9997) in the concentration ranges of 1.00–10.0 and 0.10–1.00 μg band−1 for aliskiren and hydrochlorothiazide. The limit of detection and limit of quantitation of the validated method were 0.206 and 0.624 μg band−1 for aliskiren and 0.015 and 0.046 μg band−1 for hydrochlorothiazide, respectively. The % expected content of aliskiren and hydrochlorothiazide in the commercial tablet formulation was 99.2% and 101.3%, respectively. For spiked plasma sample preparation, the analytes and nebivolol internal standard were extracted from 500 μL of plasma sample by solid-phase extraction on LiChrosep® DVB-HL cartridges. The mean extraction recovery of aliskiren and hydrochlorothiazide from human plasma was 87.2% and 76.5%, respectively. In addition, the stability of the analytes in plasma was established under different 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.

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