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<p>Acyclovir is the most utilized and effective nucleoside analog antiviral drug for the treatment of <i>Herpes simplex</i> infections. In this study, an accurate and sensitive HPLC-UV method was developed for the determination of acyclovir in the presence of preservatives (<i>p</i>-hydroxybenzoates, i.e. methylparaben and propylparaben) as recommended in the latest regulations of the pharmaceutical industry. A Phenomenex Gemini C18 (250.0 × 4.6 mm, 5.0 μm) analytical column was used for the chromatographic separation with a mobile phase mixture of methanol and 11.4 mM ortho-phosphoric acid on gradient elution. A 1.0 mL/min flow rate, 5.0 μL of injection volume and 30°C temperature were maintained throughout the study. Three different formulations, tablet, cream, and suspension were used for validation to conduct precision parameters. The developed HPLC method was found to be linear (R<sup>2</sup> = 0.9979 – 0.9997), accurate (recoveries 99.4 – 101.3 %), precise (RSD ≤ 2.0 %) and robust. The method presents a good application for both antiviral drugs and preservatives, as well as confirming its potential for being used in quality control studies and screening methods.</p>

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Determination of Acyclovir and Parabens Using HPLC in Different Pharmaceutical Formulations

  • 期刊论文

  • 发表日期：

    2025年1月1日

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  • Ceren Okuyucu Genç,
  • Ýkbal Sarýkaya Yýldýz,
  • Sena Caglar-Andac

摘要

Acyclovir is the most utilized and effective nucleoside analog antiviral drug for the treatment of Herpes simplex infections. In this study, an accurate and sensitive HPLC-UV method was developed for the determination of acyclovir in the presence of preservatives (p-hydroxybenzoates, i.e. methylparaben and propylparaben) as recommended in the latest regulations of the pharmaceutical industry. A Phenomenex Gemini C18 (250.0 × 4.6 mm, 5.0 μm) analytical column was used for the chromatographic separation with a mobile phase mixture of methanol and 11.4 mM ortho-phosphoric acid on gradient elution. A 1.0 mL/min flow rate, 5.0 μL of injection volume and 30°C temperature were maintained throughout the study. Three different formulations, tablet, cream, and suspension were used for validation to conduct precision parameters. The developed HPLC method was found to be linear (R2 = 0.9979 – 0.9997), accurate (recoveries 99.4 – 101.3 %), precise (RSD ≤ 2.0 %) and robust. The method presents a good application for both antiviral drugs and preservatives, as well as confirming its potential for being used in quality control studies and screening methods.