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Background <p>The current studies involve the development of a liquid chromatographic method that is highly effective (HPLC) for the Lumateperone Tosylate method that is simple, rapid, accurate, precise, and economical, all made possible by analytical quality by design (AQbD). The HPLC method’s experimental settings were multivariately optimised by using the design of experiments to determine critical method parameters, and the Ishikawa diagram was used for risk assessment. A two-factor, three-level design was used for the factor screening investigations. Mathematical models were created using two independent factors: the buffer’s pH and the composition of the mobile phase. The response surface methodology and the impacts of these independent aspects were thoroughly examined using central composite design, which allowed for the evaluation of the critical method attributes (CMAs). The parameters of method robustness include retention time, peak area, and symmetry factor. Utilising the desirability function, the optimisation of the CMAs took place at the same time.</p> Results <p>According to the contour diagram’s optimised data, 10 mM ammonium acetate buffer (pH = 3.2): acetonitrile (80:20 v/v) was selected as a mobile phase with a 1 mL/min flow rate. A Zorbax SB C18 250 × 4.6 mm, 5 μ chromatographic column with a UV detector at 230 nm was used and oven temperature was maintained at 25 °C. Lumateperone Tosylate showed linearity in the concentration range of 25–250&#xa0;µg/mL (r<sup>2</sup> = 0.9921). % RSD for interday and intraday precision was found to be 0.25–0.52 and 0.12–0.32, respectively. The % assay of drug content was found to be 100.01 ± 0.06, and accuracy was found to be 100.30–100.65%. In compliance with ICH recommendations, the optimised assay conditions were validated.</p> Conclusion <p>Therefore, it was clearly shown from the results that the AQbD methodology could be effectively used to optimise the HPLC method for Lumateperone Tosylate analysis. The technique was used to assess the Lumateperone Tosylate content in capsules as well.</p>

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Application of the quality by design (QbD) approach to the development and validation of analytical methods for the quantification of Lumateperone Tosylate as the bulk drug and capsule dosage form by HPLC

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  • 发表日期：

    2025年2月25日

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  • Vasudha S. Bavadekar,
  • Angha M. Joshi,
  • Ujwala S. Desai

摘要

Background

The current studies involve the development of a liquid chromatographic method that is highly effective (HPLC) for the Lumateperone Tosylate method that is simple, rapid, accurate, precise, and economical, all made possible by analytical quality by design (AQbD). The HPLC method’s experimental settings were multivariately optimised by using the design of experiments to determine critical method parameters, and the Ishikawa diagram was used for risk assessment. A two-factor, three-level design was used for the factor screening investigations. Mathematical models were created using two independent factors: the buffer’s pH and the composition of the mobile phase. The response surface methodology and the impacts of these independent aspects were thoroughly examined using central composite design, which allowed for the evaluation of the critical method attributes (CMAs). The parameters of method robustness include retention time, peak area, and symmetry factor. Utilising the desirability function, the optimisation of the CMAs took place at the same time.

Results

According to the contour diagram’s optimised data, 10 mM ammonium acetate buffer (pH = 3.2): acetonitrile (80:20 v/v) was selected as a mobile phase with a 1 mL/min flow rate. A Zorbax SB C18 250 × 4.6 mm, 5 μ chromatographic column with a UV detector at 230 nm was used and oven temperature was maintained at 25 °C. Lumateperone Tosylate showed linearity in the concentration range of 25–250 µg/mL (r2 = 0.9921). % RSD for interday and intraday precision was found to be 0.25–0.52 and 0.12–0.32, respectively. The % assay of drug content was found to be 100.01 ± 0.06, and accuracy was found to be 100.30–100.65%. In compliance with ICH recommendations, the optimised assay conditions were validated.

Conclusion

Therefore, it was clearly shown from the results that the AQbD methodology could be effectively used to optimise the HPLC method for Lumateperone Tosylate analysis. The technique was used to assess the Lumateperone Tosylate content in capsules as well.