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Purpose <p>The focus of the study was to develop and validate an optimized green-HPLC method for the estimation of simvastatin (SVS) in liposomes.</p> Methods <p>An isocratic optimized HPLC method was developed utilizing analytical quality-by-design (AQbD) methodology and validated as per the ICH Q2 (R1) guidelines using the C18 column. After method optimization, a mobile phase of 30 mM ammonium acetate buffer (pH 3.5) and methanol in a ratio of 18:82% v/v was used. The analysis was performed with a DAD detector at 238 nm with a 0.8 mL/min flow rate. The stability assessment of SVS was performed by carrying out a forced degradation study. Additionally, analytical greenness was calculated using GAPI and AGREE tools.</p> Results <p>A developed HPLC method exhibited excellent linearity (r<sup>2</sup> = 0.9999), precision, accuracy, selectivity, and sensitivity with robustness. The study revealed that there is no interference on the SVS peak due to degradants. Furthermore, the presence of formulation excipients did not show any impact on the drug peak during the total drug content and the entrapped drug estimation. The limit of detection and the limit of quantification were determined to be 38 ng/mL and 115 ng/mL, respectively. Additionally, the forced degradation investigation demonstrated the stability of SVS in several mediums and conditions. Moreover, the developed optimized HPLC method was identified as a green method based on AGREE and GAPI scores.</p> Conclusion <p>This investigation concludes that the developed optimized method is selective, sensitive, precise, accurate, reproducible and green. Hence, it is useful for the estimation of SVS in liposomes and other pharmaceutical dosage forms.</p> Graphical Abstract <p></p>

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An AQbD-based Optimized and Green Isocratic HPLC Method for the Quantification of Simvastatin in Liposomes: Forced Degradation, Assessment of Drug Content, and Drug Entrapment

  • 期刊论文

  • 发表日期：

    2025年6月5日

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  • Arka Karmakar,
  • Sampada Shinde,
  • Varla Yalamanda,
  • Yogesh Khairnar,
  • Subhrasima Nayak,
  • Lalit Kumar

摘要

Purpose

The focus of the study was to develop and validate an optimized green-HPLC method for the estimation of simvastatin (SVS) in liposomes.

Methods

An isocratic optimized HPLC method was developed utilizing analytical quality-by-design (AQbD) methodology and validated as per the ICH Q2 (R1) guidelines using the C18 column. After method optimization, a mobile phase of 30 mM ammonium acetate buffer (pH 3.5) and methanol in a ratio of 18:82% v/v was used. The analysis was performed with a DAD detector at 238 nm with a 0.8 mL/min flow rate. The stability assessment of SVS was performed by carrying out a forced degradation study. Additionally, analytical greenness was calculated using GAPI and AGREE tools.

Results

A developed HPLC method exhibited excellent linearity (r2 = 0.9999), precision, accuracy, selectivity, and sensitivity with robustness. The study revealed that there is no interference on the SVS peak due to degradants. Furthermore, the presence of formulation excipients did not show any impact on the drug peak during the total drug content and the entrapped drug estimation. The limit of detection and the limit of quantification were determined to be 38 ng/mL and 115 ng/mL, respectively. Additionally, the forced degradation investigation demonstrated the stability of SVS in several mediums and conditions. Moreover, the developed optimized HPLC method was identified as a green method based on AGREE and GAPI scores.

Conclusion

This investigation concludes that the developed optimized method is selective, sensitive, precise, accurate, reproducible and green. Hence, it is useful for the estimation of SVS in liposomes and other pharmaceutical dosage forms.

Graphical Abstract