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Purpose <p>The Pharmacokinetic parameters were determined, and IVIVC has been proved in the current research work of formulated novel chronosystem (ChrDDS) of perindopril erbumine (PER).</p> Methods <p>To assess pure drug in the rabbit plasma, a swift, precise, and highly sensitive HPLC method was built. The time-dependent mobility of the ChrDDS was observed using radiography (X-ray). A Level A IVIVC relationship was established between the fraction of drug released (FDR) and the fraction of drug absorbed (FDA). The stability testing was performed for 180 days following ICH Q1A (R2) guidelines.</p> Results <p>Using a 30:25:45 methanol, acetonitrile, and phosphate buffer mixture having a pH of 2.6, the PER retention time was 4.880&#xa0;min. The drug was released in a pulsatile manner, up to 24&#xa0;h in the in vitro dissolution study, with two lag phases. The in-vivo pharmacokinetics revealed that the C<sub>max</sub> for PER ChrDDS was 111.41 ± 14.35 ng/ml, with a T<sub>max</sub> of 8&#xa0;h and an MRT of 12.63 ± 1.81&#xa0;h. The level-A IVIVC was validated by the correlation coefficient of 0.9894.</p> Conclusion <p>There were no discernible alterations in the physical characteristics, cumulative percentage release, or PER content, according to the stability estimation. Meeting all the requirements for hypertension chronotherapy, this study has the potential to be expanded in the future.</p>

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Bioanalytical Method Development, Pharmacokinetic Determination, and Time-Dependent Mobility of a Novel Chronosystem of ACE Inhibitor

  • 期刊论文

  • 发表日期：

    2025年7月30日

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  • Saniya Jawed,
  • Satish CS,
  • Vimal Kumar

摘要

Purpose

The Pharmacokinetic parameters were determined, and IVIVC has been proved in the current research work of formulated novel chronosystem (ChrDDS) of perindopril erbumine (PER).

Methods

To assess pure drug in the rabbit plasma, a swift, precise, and highly sensitive HPLC method was built. The time-dependent mobility of the ChrDDS was observed using radiography (X-ray). A Level A IVIVC relationship was established between the fraction of drug released (FDR) and the fraction of drug absorbed (FDA). The stability testing was performed for 180 days following ICH Q1A (R2) guidelines.

Results

Using a 30:25:45 methanol, acetonitrile, and phosphate buffer mixture having a pH of 2.6, the PER retention time was 4.880 min. The drug was released in a pulsatile manner, up to 24 h in the in vitro dissolution study, with two lag phases. The in-vivo pharmacokinetics revealed that the Cmax for PER ChrDDS was 111.41 ± 14.35 ng/ml, with a Tmax of 8 h and an MRT of 12.63 ± 1.81 h. The level-A IVIVC was validated by the correlation coefficient of 0.9894.

Conclusion

There were no discernible alterations in the physical characteristics, cumulative percentage release, or PER content, according to the stability estimation. Meeting all the requirements for hypertension chronotherapy, this study has the potential to be expanded in the future.