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Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method

Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of... Abstract The principle motive behind this work is to develop robust, low cost, and regulatory flexible method for Tadalafil and Macitentan by RP-HPLC using Analytical Quality by Design principles. Failure Mode and Effects Analysis was performed and the risk priority number was calculated, from this analysis independent variables were selected. Optimization of chromatographic condition was performed using Central Composite Design. The separation was achieved using phenomex gemini C18 (150 mm, 4.6 mm, 5μm) column using mobile phase as methanol: 10 mM ammonium formate (74.1 : 25.9 % v/v) (pH: 6.8) at a flow rate 0.94 ml/ min with detection wavelength at 260 nm and 40°C column oven temperature. This method was validated according to ICH Q2 (R1) guideline. Analytical Quality by Design method was numerically optimized with a desirability of 1.0. ANOVA result shows that model was significant for all responses. The method was found to be linear in the range of 0.1-25 μg/ml for Macitentan and 0.4-100 μg/ml for Tadalafil. Percentage recovery was found in the range of 98.6-101.7 % for Macitentan and 98.8-101.8 % for Tadalafil. The RSD of precision and repeatability was found beneath 1 %. AQbD driven method can be highly suitable for analysis of Tadalafil and Macitentan without interference. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method

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Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method

Abstract

Abstract The principle motive behind this work is to develop robust, low cost, and regulatory flexible method for Tadalafil and Macitentan by RP-HPLC using Analytical Quality by Design principles. Failure Mode and Effects Analysis was performed and the risk priority number was calculated, from this analysis independent variables were selected. Optimization of chromatographic condition was performed using Central Composite Design. The separation was achieved using phenomex gemini C18 (150 mm,...
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Publisher
Taylor & Francis
Copyright
© 2021 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2021.1938215
Publisher site
See Article on Publisher Site

Abstract

Abstract The principle motive behind this work is to develop robust, low cost, and regulatory flexible method for Tadalafil and Macitentan by RP-HPLC using Analytical Quality by Design principles. Failure Mode and Effects Analysis was performed and the risk priority number was calculated, from this analysis independent variables were selected. Optimization of chromatographic condition was performed using Central Composite Design. The separation was achieved using phenomex gemini C18 (150 mm, 4.6 mm, 5μm) column using mobile phase as methanol: 10 mM ammonium formate (74.1 : 25.9 % v/v) (pH: 6.8) at a flow rate 0.94 ml/ min with detection wavelength at 260 nm and 40°C column oven temperature. This method was validated according to ICH Q2 (R1) guideline. Analytical Quality by Design method was numerically optimized with a desirability of 1.0. ANOVA result shows that model was significant for all responses. The method was found to be linear in the range of 0.1-25 μg/ml for Macitentan and 0.4-100 μg/ml for Tadalafil. Percentage recovery was found in the range of 98.6-101.7 % for Macitentan and 98.8-101.8 % for Tadalafil. The RSD of precision and repeatability was found beneath 1 %. AQbD driven method can be highly suitable for analysis of Tadalafil and Macitentan without interference.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Jul 4, 2021

Keywords: Analytical Quality by Design; simultaneous estimation; failure mode and effects analysis; tadalafil; macitentan

References

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