ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR BY REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND TABLET DOSAGE FORMS


Sufiyan Ahmad, Mohammed Rageeb Mohammed Usman

Abstract


 

 Objective: A simple rapid, accurate, precise, and reproducible validated reversed-phase high performance liquid chromatography method was developed for the determination of emtricitabine (EMB) and tenofovir (TEN) in bulk and tablet dosage forms.

Methods: The quantification was carried out using symmetry Premsil C18 (250 mm×4.6 mm, 5 μm) Younglin (S.K.) gradient way using mobile phase comprising of methanol:water (70:30 v/v) pH 3 and a detection wavelength of 273 nm, and injection volume of 20 μL, with a flow rate of 1 ml/minutes.

Results: In the developed method, the retention time of EMB and TEN were found to be 3.1667 minutes and 7.5000 minutes. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines.

Conclusion: The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence, the method was found to be simple, accurate, precise, economic, and reproducible. Hence, it is worthwhile that the proposed methods can be successfully utilized for the routine quality control analysis EMB and TEN in bulk drug as well as in formulations.


Keywords


Emtricitabine and tenofovir, Method development, Validation, Simultaneous estimation, High performance liquid chromatography.

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References


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About this article

Title

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR BY REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND TABLET DOSAGE FORMS

Topics

Pharmaceutical Sciences

Keywords

Emtricitabine and tenofovir, Method development, Validation, Simultaneous estimation, High performance liquid chromatography.

DOI

10.22159/ajpcr.2017.v10i11.20477

Date

01-11-2017

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 10 Issue 11 November 2017 Page: 59-64

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

26 Views | 70 Downloads

Authors & Affiliations

Sufiyan Ahmad
Department of Quality Assurance, Gangamai College of Pharmacy, Nagaon, Dist. Dhule (M.S.), India.
India

Mohammed Rageeb Mohammed Usman
Department of Pharmacognosy, Smt. S. S. Patil College of Pharmacy, Chopda, Maharashtra, India
India


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