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Simultaneous Quantification of Lamivudine, Tenofovir Disoproxil Fumarate and Doravirine in Pharmaceutical Dosage Form by Liquid Chromatography with Diode Array Detection

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Pharmaceutical Chemistry Journal Aims and scope

A new simple, precise and robust isocratic reverse-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for simultaneous determination of lamivudine, tenofovir disoproxil fumarate (TDF), and doravirine in bulk and pharmaceutical dosage form. The validation included specificity, linearity, system suitability, precision, robustness, LOD and LOQ characteristics. The chromatographic separation was achieved on C18X bridge phenyl column (150 × 4.6 mm, 3 μm particle size) eluted with acetonitrile and hexane-1-sulfonic acid (pH 2.5; 50:50, v/v) at a flow rate of 0.8 mL/min and monitored at 243 nm over a run time of 12 min. The retention times of lamivudine, TDF, and doravirine were found to be 2.45, 7.3, and 8.79 min. respectively. The method was linear in the range of 5 – 100 μg/mL (r2 = 0.999) for lamivudine and TDF and in the range of 1.75 – 35 μg/mL (r2 = 0.999) for doravirine. The percentage recoveries of three drugs were within the acceptable limits (98 – 102%). The method was found to be precise as confirmed by % RSD < 0.6. Forced degradation study was conducted as per ICH guidelines, and the three drugs showed degradation within 21.4 – 33.8% under acidic, basic, oxidative, photolysis, and hydrolysis conditions. The proposed RP-HPLC method can be used for the quantification of lamivudine, TDF, and doravirine in API and tablets without any interference from excipients.

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Acknowledgements

The authors are thankful to Maharajah’s College of Pharmacy (Vizianagaram, India) and GITAM Institute of Pharmacy (Visakhapatnam, India) for supporting and providing necessary facilities for the research work.

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Authors and Affiliations

  1. Department of Pharmaceutical Analysis, Maharajah’s College of Pharmacy, Phool Baugh, Vizianagaram, Andhra Pradesh, -535002, India

    Gowri Gollu

  2. Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, -530045, India

    Sowjanya Gummadi

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  1. Gowri Gollu
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  2. Sowjanya Gummadi
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Correspondence to Gowri Gollu.

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Gollu, G., Gummadi, S. Simultaneous Quantification of Lamivudine, Tenofovir Disoproxil Fumarate and Doravirine in Pharmaceutical Dosage Form by Liquid Chromatography with Diode Array Detection. Pharm Chem J 54, 526–535 (2020). https://doi.org/10.1007/s11094-020-02232-9

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  • DOI: https://doi.org/10.1007/s11094-020-02232-9

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