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. 2016 May-Jun;54(5):759-64.
doi: 10.1093/chromsci/bmw004. Epub 2016 Feb 9.

A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form

Chinnalalaiah Runja  1 , Pigili Ravi Kumar  2 , Srinivasa Rao Avanapu  3
Affiliations

A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form

Chinnalalaiah Runja et al. J Chromatogr Sci. 2016 May-Jun.

Abstract

A new simple, rapid stability indicating assay method has been developed and validated for the determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat using reverse-phase high-performance liquid chromatography in their pharmaceutical dosage form. The chromatographic separation was performed on an ODS column (250 × 4.6 mm, 5 µm) using mobile phase A (potassium dihydrogen orthophosphate, pH adjusted to 2.5) and mobile phase B (acetonitrile) in the ratio of 55:45% v/v at a flow rate of 1 mL/min. The analytes were detected at 250 nm. The method was found to be linear in the concentration range of 2-12 µg/mL for EMT, 3-18 µg/mL for TNDF, 1.5-9 µg/mL for ELV and COB, with the coefficient value (R(2)) of >0.9990. The accuracy was measured via recovery studies and found to be acceptable, and the percentage recoveries were found in the range of 99.93-100.08 ± 0.5%. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic and thermal degradation. The proposed method was successfully validated and applied for the quantitative estimation of these drugs in both bulk and tablet dosage forms.

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Figures

Figure 1.
Figure 1.
Chemical structures of (A) emtricitabine, (B) tenofovir disoproxil fumarate, (C) elvitegravir and (D) cobicistat.
Figure 2.
Figure 2.
Chromatograms of forced degradation studies. (A) Undegraded standard chromatogram of EMT, TNDF, ELV and COB. (B) Acid degradation. (C) Alkali degradation. (D) Peroxide degradation. (E) Thermal degradation. (F) Photolytic degradation.
Figure 2.
Figure 2.
Chromatograms of forced degradation studies. (A) Undegraded standard chromatogram of EMT, TNDF, ELV and COB. (B) Acid degradation. (C) Alkali degradation. (D) Peroxide degradation. (E) Thermal degradation. (F) Photolytic degradation.
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