Pharma Focus Asia

Validated Spectrometric Determination Of Penciclovir And Entecavir In Bulk And In Pharmaceutical Preparations

Authors: Asmaa A. Elzahera, Marwa A. Fouad, Ola M. Elhoussini, Yasmine Essam-Eldin Behery

Abstract:

Simple, rapid and sensitive spectroscopic methods were developed and validated for the determination of antiviral agents, namely, penciclovir (PCV) and entecavir (ETV). The first method is based on measuring the native fluorescence of each of the cited drugs at its optimum excitation and emission wavelengths. The fluorescence intensity was measured for PCV & ETV at 363 nm and 370 nm upon excitation at 260 nm and 254 nm, respectively. The calibration curves were linear over the concentration range 0.1–0.8, 0.025–0.4 μg ml−1 for PCV and ETV, respectively. The second method is based on measuring the amplitude of ETV in the fourth derivative with Δλ = 8 and scaling factor = 100 at 256.4 nm at which its acidic degradation showed zero reading over the concentration range 5–60 μg ml−1. The proposed methods were applied for the determination of the cited drugs in bulk and pharmaceutical preparations. ICH guidelines were used for method validation.

Keywords

Derivative; Acidic degradation; Penciclovir; Entecavir; Native fluorescence

Citaiton: Asmaa A. Elzahera, Marwa A. Fouad, Ola M. Elhoussini, Yasmine Essam-Eldin Behery Validated Spectrometric Determination Of Penciclovir And Entecavir In Bulk And In Pharmaceutical Preparations  http://dx.doi.org/10.1016/j.bfopcu.2016.05.002

Received: 12 January 2016, Revised: 29 April 2016, Accepted: 8 May 2016, Available online: 6 June 2016

Copyright: © 2016 Production and hosting by Elsevier B.V. on behalf of Faculty of Pharmacy, Cairo University.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Conclusion

The proposed spectroscopic methods have the advantage of simplicity, precision, accuracy, and convenience for the determination of the cited antiviral drugs: penciclovir and entecavir. Hence, the proposed methods can be used for the routine quality control of the cited drugs in bulk and in pharmaceutical preparations in laboratories.

Conflict of interest

None declared.

magazine-slider-imageCytiva - Supor Prime filtersMFA + MMA 2024CPHI China || PMEC China 2024Asia Healthcare Week 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference3rd World ADC Asia 2024LogiPharma Asia 2024