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. 2023 Jun 27:12:468.
doi: 10.12688/f1000research.132841.2. eCollection 2023.

Advancing posaconazole quantification analysis with a new reverse-phase HPLC method in its bulk and marketed dosage form

Annamalai Rama  1 , Induja Govindan  1 , Srinivas Hebbar  1 , Abhishek Chaturvedi  2 , Usha Rani  3 , Anup Naha  1
Affiliations

Advancing posaconazole quantification analysis with a new reverse-phase HPLC method in its bulk and marketed dosage form

Annamalai Rama et al. F1000Res. .

Abstract

Introduction: Posaconazole is a widely used antifungal drug, and its accurate quantification is essential for quality control and assessment of its pharmaceutical products. This study aimed to develop and validate a reverse-phase high-performance liquid chromatography (HPLC) analytical method for quantifying Posaconazole in bulk and dosage form. Methods: The HPLC method was developed and validated based on International Conference on Harmonisation (ICH) guidelines. The developed method was then applied to quantify Posaconazole in a marketed tablet formulation. The method's specificity, linearity, precision, accuracy, robustness, and stability were evaluated. Results: The developed HPLC method showed good linearity over a 2-20 μg/mL concentration range. The percentage recovery of Posaconazole from the bulk and marketed formulations was found to be 99.01% and 99.05%, respectively. The intra-day and inter-day precisions were less than 1%, and the method was stable under different conditions. The HPLC method was successfully applied to quantify Posaconazole in the marketed formulation. Conclusion: The developed and validated HPLC method is reliable and efficient for analyzing Posaconazole in bulk and dosage forms. The method's accuracy, precision, specificity, linearity, robustness, and stability demonstrate its effectiveness. The method can be used for the quality control and assessment of Posaconazole-containing pharmaceutical products.

Keywords: Analytical method; HPLC; Posaconazole; Quality control; Validation.

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Conflict of interest statement

No competing interests were disclosed.

Figures

Figure 1.
Figure 1.. UV spectrum of Posaconazole to determine its absorption maxima in different concentrations.
Figure 2.
Figure 2.. Chromatograms of initial trials of method development.
Figure 3.
Figure 3.. Chromatogram of the Posaconazole with Blank.
Figure 4.
Figure 4.. Mean linearity chart.
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