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Background <p>The major focus of the research was to optimize and validate an eco-friendly, cost-effective, high-performance and throughput RP-HPLC technique for the quantification of Cinnarizine in marketed formulation and also evaluate intrinsic stability. Further, the proposed analytical method efficiency was compared with three reported methods using green and white algorithmic matrix viz., AES, AGREE, GAPI, RGB and BAGI.</p> Results <p>Chromatographic conditions were optimized with Inertsil ODS-3V column (250 × 4.6&#xa0;mm, 5&#xa0;μm) with methanol and 0.1% v/v orthophosphoric acid (pH 2.5) in a 95:05 v/v ratio as mobile phase. The analytical wavelength and flow rate were fixed to 254&#xa0;nm and 0.5&#xa0;mL&#xa0;min<sup>−1</sup>, respectively. Inherent stability profile was also carried out as per ICH Q<sub>1</sub>A R<sub>2</sub> guidelines. The Cinnarizine was eluted from the column at 3.328&#xa0;min and the method was validated in accordance with ICH Q<sub>2</sub> R<sub>1</sub>. The optimum linearity of the analytical method was fitting over the range of 2–14&#xa0;µg&#xa0;mL<sup>−1</sup> with a correlation constant of 0.9992. The limits of detection and quantification were 0.00621&#xa0;µg&#xa0;mL<sup>−1</sup> and 0.0207&#xa0;µg&#xa0;mL<sup>−1</sup>, respectively. The Cinnarizine was found to be stable in acidic, thermal and photolytic conditions. Whereas, maximum degradation has taken place in basic and oxidative degradation. The Greenness and whiteness of the optimized chromatographic conditions were better than those reported methods.</p> Conclusion <p>Overall, the optimized RP-HPLC method can be utilized for the quantification of Cinnarizine in the tablet formulation and to generate the stability profile.</p>

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A validated RP-HPLC method for the estimation of Cinnarizine in tablet formulation: evaluation of intrinsic stability, greenness and whiteness matrices

  • 期刊论文

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  • 发表日期：

    2025年10月6日

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  • Jangamarahalli Nataraju Vedashri,
  • Veeresh Prabhakar Veerapur,
  • Srinivasa Rajeev,
  • Ranganatha Puttaraju,
  • Siddaraju Nagashree,
  • DeviReddy Prashanthi,
  • Mathad Shivamurthaiah Chaithanya

摘要

Background

The major focus of the research was to optimize and validate an eco-friendly, cost-effective, high-performance and throughput RP-HPLC technique for the quantification of Cinnarizine in marketed formulation and also evaluate intrinsic stability. Further, the proposed analytical method efficiency was compared with three reported methods using green and white algorithmic matrix viz., AES, AGREE, GAPI, RGB and BAGI.

Results

Chromatographic conditions were optimized with Inertsil ODS-3V column (250 × 4.6 mm, 5 μm) with methanol and 0.1% v/v orthophosphoric acid (pH 2.5) in a 95:05 v/v ratio as mobile phase. The analytical wavelength and flow rate were fixed to 254 nm and 0.5 mL min−1, respectively. Inherent stability profile was also carried out as per ICH Q1A R2 guidelines. The Cinnarizine was eluted from the column at 3.328 min and the method was validated in accordance with ICH Q2 R1. The optimum linearity of the analytical method was fitting over the range of 2–14 µg mL−1 with a correlation constant of 0.9992. The limits of detection and quantification were 0.00621 µg mL−1 and 0.0207 µg mL−1, respectively. The Cinnarizine was found to be stable in acidic, thermal and photolytic conditions. Whereas, maximum degradation has taken place in basic and oxidative degradation. The Greenness and whiteness of the optimized chromatographic conditions were better than those reported methods.

Conclusion

Overall, the optimized RP-HPLC method can be utilized for the quantification of Cinnarizine in the tablet formulation and to generate the stability profile.