Evaluation of chromatographic conditions for simultaneously determination of Emtricitabine and Tenofovir

Doneva, Dragica and Shishovska, Maja and Mustafa, Zana and Memeti, Shaban and Starkoska, Katerina and Zulfikjari, Sanija and Dimitrovska, Aleksandra and Arsova-Sarafinovska, Zorica (2022) Evaluation of chromatographic conditions for simultaneously determination of Emtricitabine and Tenofovir. Macedonian pharmaceutical bulletin, 68 (1). pp. 101-102. ISSN 1857 - 8969

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Abstract

A fixed-dose combination of two antiretroviral drugs (tenofovir and emtricitabine) used for the treatment of HIV is already present on the European market. However, monographs of emtricitabine and tenofovir are not included in the actual European Pharmacopoeia. There is no official method for quality control of pharmaceutical dosage forms containing both emtricitabine and tenofovir. Therefore, the aim of this study was to optimize and to propose chromatography conditions for simultaneous identification and determination of emtricitabine and tenofovir active compounds in pharmaceutical dosage forms suitable for routine analysis in the quality control laboratories. In this study we used seven different ODS columns and we evaluate their efficiency in emtricitabine and tenofovir analysis. Testing for identification, specificity, selectivity, resolution and suitability was according to requirements in the ICH Q2(R1) Guideline (ICH, 2019). The emtricitabine and tenofovir can be successively separated with RP–HPLC octadecylsylil columns. Our experimental results showed that the optimal chromatographic conditions for simultaneous HPLC analysis of emtricitabine and tenofovir are achieved with mobile phase composed of 30% acetonitrile and 70%, water acidified with o-phosphoric acid at pH 2.6, at flowrate 1 mL/min, column oven set at 30ºC, with specific UV detection at 260 nm for tenofovir and at 284 nm for emtricitabine. Optimal results were obtained with Lichrospher 100 C18 (250 mm x 4 mm) and Purospher C18 end capped (150 mm x 4.6 mm) columns.

Item Type:	Article
Subjects:	Medical and Health Sciences > Health sciences
Divisions:	Faculty of Medical Science
Depositing User:	Zorica Arsova Sarafinovska
Date Deposited:	05 Feb 2023 22:20
Last Modified:	05 Feb 2023 22:20
URI:	https://eprints.ugd.edu.mk/id/eprint/31356

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