Application of Quality by Design for the Optimization of an HPLC Method to Determine Ezetimibe in a Supersaturable Self-Nanoemulsifying Formulation

Rajendra Narayan DashAlliance Institute of Advanced Pharmaceutical & Health Sciences, Kukatpally, Hyderabad, Telangana, India

Mohammed HabibuddinAdept Pharma and Bioscience Excellence Private Limited, Vijayanagar Colony, Hyderabad, Telangana, IndiaCorrespondence[email protected]

Touseef HumairaAdept Pharma and Bioscience Excellence Private Limited, Vijayanagar Colony, Hyderabad, Telangana, India

Ayyub Ali PatelDepartment of Biochemistry, College of Medical Sciences, King Khalid University, Abha, Aseer, Saudi Arabia

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Lucas Chiarentin, Carla Gonçalves, Cátia Augusto, Margarida Miranda, Catarina Cardoso & Carla Vitorino. (2023) Drilling into “Quality by Design” Approach for Analytical Methods. Critical Reviews in Analytical Chemistry 0:0, pages 1-42.
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Vaskuri G. S. Sainaga Jyothi, Harithasree Veerabomma, Chantibabu Katta & Jitender Madan. (2023) Computational quality-by-design strategy to validate high-performance liquid chromatography method for the estimation of meloxicam in bulk dosage forms and milk samples. Analytical Sciences.
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Latifa Latrous. (2022) Optimization and Validation in Liquid Chromatography Using Design of Experiments. Chemistry Africa 5:3, pages 437-458.
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Tim Tome, Nina Žigart, Zdenko Časar & Aleš Obreza. (2019) Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances. Organic Process Research & Development 23:9, pages 1784-1802.
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Riccardo Deidda, Serena Orlandini, Philippe Hubert & Cédric Hubert. (2018) Risk-based approach for method development in pharmaceutical quality control context: A critical review. Journal of Pharmaceutical and Biomedical Analysis 161, pages 110-121.
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P. R. Desai, P. J. Mehta, S. K. Ojha & A. B. Chokshi. (2018) Simultaneous quantification of related substances of ezetimibe and simvastatin in combined dosage form using a novel stability-indicating liquid chromatographic method. Acta Chromatographica 30:2, pages 85-94.
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Prafulla Kumar Sahu, Nageswara Rao Ramisetti, Teresa Cecchi, Suryakanta Swain, Chandra Sekhar Patro & Jagadeesh Panda. (2018) An overview of experimental designs in HPLC method development and validation. Journal of Pharmaceutical and Biomedical Analysis 147, pages 590-611.
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Rajendra Narayan Dash, Habibuddin Mohammed & Touseef Humaira. (2015) Design, optimization, and evaluation of ezetimibe solid supersaturatable self-nanoemulsifying drug delivery for enhanced solubility and dissolution. Journal of Pharmaceutical Investigation 46:2, pages 153-168.
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Application of Quality by Design for the Optimization of an HPLC Method to Determine Ezetimibe in a Supersaturable Self-Nanoemulsifying Formulation

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Application of Quality by Design for the Optimization of an HPLC Method to Determine Ezetimibe in a Supersaturable Self-Nanoemulsifying Formulation

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