Scholarlink

Background <p>Valaciclovir is an antiviral drug that requires accurate and sensitive analytical methods for quantification in pharmaceutical formulations and biological matrices. This study presents the development and validation of two analytical techniques in accordance with ICH Q2(R2) and M10 guidelines: a reversed-phase high-performance liquid chromatography (RP-HPLC) method and a novel chromogenic UV–visible spectrophotometric method extended to biosamples.</p> Results <p>The RP-HPLC method provided rapid and precise quantification of valaciclovir, with a retention time of 3.177&#xa0;min. Linearity was observed in the range of 10–60&#xa0;µg/mL, with a limit of detection of 0.0702&#xa0;µg/mL and a limit of quantification of 0.2128&#xa0;µg/mL. The method demonstrated high accuracy, specificity, and reproducibility, making it suitable for routine pharmaceutical analysis. The second method involved a chromogenic reaction between valaciclovir and MBTH reagent in the presence of ferric ammonium sulfate, forming a green chromogen with maximum absorbance at 618&#xa0;nm. This method showed linearity from 10 to 550&#xa0;µg/mL and further the method was validated as per ICH M10 guidelines. For biological analysis, human serum samples were processed using a protein precipitation method and analyzed successfully. Validation confirmed its suitability for bioanalytical use.</p> Conclusions <p>Both methods are sensitive, accurate, and validated for the quantification of valaciclovir. RP-HPLC is ideal for pharmaceutical analysis, while the UV–visible method offers a simple, cost-effective alternative for biological samples.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

RP-HPLC-UV method for estimation of antiviral drug (Valaciclovir) in pure, solid dosage form and spiked human plasma using MBTH reagent as per ICH guidelines

  • 期刊论文

  • 发表日期：

    2025年6月16日

查看全文
  • K. Bhavya Sri,
  • A. Vaishnavi,
  • J. Pravallika,
  • Mogili Sumakanth

摘要

Background

Valaciclovir is an antiviral drug that requires accurate and sensitive analytical methods for quantification in pharmaceutical formulations and biological matrices. This study presents the development and validation of two analytical techniques in accordance with ICH Q2(R2) and M10 guidelines: a reversed-phase high-performance liquid chromatography (RP-HPLC) method and a novel chromogenic UV–visible spectrophotometric method extended to biosamples.

Results

The RP-HPLC method provided rapid and precise quantification of valaciclovir, with a retention time of 3.177 min. Linearity was observed in the range of 10–60 µg/mL, with a limit of detection of 0.0702 µg/mL and a limit of quantification of 0.2128 µg/mL. The method demonstrated high accuracy, specificity, and reproducibility, making it suitable for routine pharmaceutical analysis. The second method involved a chromogenic reaction between valaciclovir and MBTH reagent in the presence of ferric ammonium sulfate, forming a green chromogen with maximum absorbance at 618 nm. This method showed linearity from 10 to 550 µg/mL and further the method was validated as per ICH M10 guidelines. For biological analysis, human serum samples were processed using a protein precipitation method and analyzed successfully. Validation confirmed its suitability for bioanalytical use.

Conclusions

Both methods are sensitive, accurate, and validated for the quantification of valaciclovir. RP-HPLC is ideal for pharmaceutical analysis, while the UV–visible method offers a simple, cost-effective alternative for biological samples.